Cleared Traditional

K990810 - ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING

K990810 · Maersk Medical, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1999
Decision
190d
Days
-
Risk

K990810 is an FDA 510(k) clearance for the ARGLAES-AB ANTIMICROBIAL BARRIER FILM DRESSING & ISLAND DRESSING. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Maersk Medical, Ltd. (St Louis, US). The FDA issued a Cleared decision on September 17, 1999 after a review of 190 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 Maersk Medical, Ltd. devices

FDA 510(k) Submission Details - K990810

510(k) Number K990810 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1999
Decision Date September 17, 1999
Days to Decision 190 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
75d slower than avg
Panel avg: 115d · This submission: 190d
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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