Cleared Traditional

K980779 - THALAFIX NATURAL SEA SALT DRESSING

K980779 is an FDA 510(k) clearance for THALAFIX NATURAL SEA SALT DRESSING, manufactured by Dumex Medical Surgical Products, Ltd.. The device is a Class 1 General & Plastic Surgery device with product code KMF cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K980779 · Dumex Medical Surgical Products, Ltd. · General & Plastic Surgery device
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Jun 1998
Decision
116d
Days
Class 1
Risk

K980779 is an FDA 510(k) clearance for the THALAFIX NATURAL SEA SALT DRESSING. Classified as Bandage, Liquid (product code KMF), Class I - General Controls.

Submitted by Dumex Medical Surgical Products, Ltd. (Toronto, Orntario, CA). The FDA issued a Cleared decision on June 26, 1998 after a review of 116 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5090 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Dumex Medical Surgical Products, Ltd. devices

FDA 510(k) Submission Details - K980779

510(k) Number K980779 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received March 02, 1998
Decision Date June 26, 1998
Days to Decision 116 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 115d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

KMF Device Classification - Class 1, General Controls

Product Code KMF Bandage, Liquid
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5090
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMF Bandage, Liquid

All 121
Devices cleared under the same product code (KMF) and FDA review panel - the closest regulatory comparables to K980779.
HOSPAL TIPSTOP
K982818 · Gambro Healthcare · Oct 1998
AQUACEL HYDROFIBER WOUND DRESSING
K982116 · Convatec, A Bristol-Myers Squibb Co. · Sep 1998
AL-GEN CALCIUM ALGINATE DRESSING
K982234 · Innovative Technologies , Ltd. · Sep 1998
3M TEGAGEN HI ALGINATE DRESSING & 3M TEGAGEN HG ALGINATE DRESSING
K980989 · Innovative Technologies , Ltd. · May 1998
SPYROSORB FOAM ISLAND WOUND DRESSING
K980673 · Innovative Technologies (Us), Inc. · May 1998
DUMEX PAK-ITS NON-WOVEN DRESSING IMPREGNATED SITH SODIUM CHLORIDE (HYPERTONIC)
K980863 · Dumex Medical Surgical Products, Ltd. · May 1998