Cleared Traditional

K930401 - ALUMINUM FOIL

K930401 · Gam Industries, Inc. · General & Plastic Surgery device
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May 1993
Decision
106d
Days
-
Risk

K930401 is an FDA 510(k) clearance for the ALUMINUM FOIL. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Gam Industries, Inc. (Petersburg, US). The FDA issued a Cleared decision on May 12, 1993 after a review of 106 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 Gam Industries, Inc. devices

FDA 510(k) Submission Details - K930401

510(k) Number K930401 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date May 12, 1993
Days to Decision 106 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 115d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

MGP Device Classification - Class 0,

Product Code MGP Dressing, Wound And Burn, Occlusive
Device Class -

Regulatory Peers - MGP Dressing, Wound And Burn, Occlusive

All 58
Devices cleared under the same product code (MGP) and FDA review panel - the closest regulatory comparables to K930401.
POLYSKIN(R) M.R. MOIST RESPONSIVE TRANSPARENT DRESSING
K942774 · The Kendal Co. · Jul 1994
CUTIFILM(R) FILM
K926399 · Beiersdorf, Inc. · Nov 1993
HYDRASORB STERILE DRESSING
K931599 · Calgon Vestal Div. · Jul 1993
EPI-LOCK WOUND DRESSING
K926034 · Calgon Vestal Div. · Apr 1993
DEROYAL TRANSPARENT FILM DRESSIGN
K920796 · Deroyal Industries, Inc. · Jul 1992
PROCEL BURN COVER
K915695 · W.L. Gore & Associates, Inc. · May 1992