Cleared Traditional

K934267 - DAMOR CREAM SATURATED DRESSING

K934267 · Damor America, Inc. · General & Plastic Surgery device
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Dec 1993
Decision
98d
Days
-
Risk

K934267 is an FDA 510(k) clearance for the DAMOR CREAM SATURATED DRESSING. Classified as Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic (product code MGQ).

Submitted by Damor America, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on December 7, 1993 after a review of 98 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel. 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 Damor America, Inc. devices

FDA 510(k) Submission Details - K934267

510(k) Number K934267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1993
Decision Date December 07, 1993
Days to Decision 98 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

MGQ Device Classification - Class 0,

Product Code MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic
Device Class -

Regulatory Peers - MGQ Dressing, Wound And Burn, Hydrogel W/drug And/or Biologic

All 91
Devices cleared under the same product code (MGQ) and FDA review panel - the closest regulatory comparables to K934267.
CURAFIL WOUND GEL DRESSING
K943073 · Kendall Healthcare Products Co. Div.Of Tyco Health · Jul 1994
BIOLEX IMPREGNATED WOUND DRESSING
K935096 · C.R. Bard, Inc. · Feb 1994
DUODERM IMPROVED CGF CONTROL GEL FORMULA DRESSING
K932101 · Convatec, A Division of E.R. Squibb & Sons · Dec 1993
SOLOSITE DERMAL WOUND GEL
K932263 · Smith & Nephew United, Inc. · Oct 1993
DERMAGRAN WET DRESSING (ZINC-SALINE)
K913344 · Derma Sciences, Inc. · Jul 1992
DERMAGRAN WET DRESSING
K914746 · Derma Sciences, Inc. · Jun 1992