Cleared Traditional

K981299 - SILVERLON CONTACT WOUND DRESSING

K981299 · Argentum International, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1998
Decision
169d
Days
-
Risk

K981299 is an FDA 510(k) clearance for the SILVERLON CONTACT WOUND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Argentum International, LLC (Lakemont, US). The FDA issued a Cleared decision on September 25, 1998 after a review of 169 days - an extended review cycle.

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 Argentum International, LLC devices

FDA 510(k) Submission Details - K981299

510(k) Number K981299 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1998
Decision Date September 25, 1998
Days to Decision 169 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 115d · This submission: 169d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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