Cleared Traditional

K946338 - CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING

K946338 · Certified Safety Mfg., Inc. · General & Plastic Surgery device
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Mar 1995
Decision
90d
Days
-
Risk

K946338 is an FDA 510(k) clearance for the CERTIBURN BURN/TRAUMA FACE DRESSING, TOWEL DRESSING. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Certified Safety Mfg., Inc. (Kansas City, US). The FDA issued a Cleared decision on March 29, 1995 after a review of 90 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 Certified Safety Mfg., Inc. devices

FDA 510(k) Submission Details - K946338

510(k) Number K946338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1994
Decision Date March 29, 1995
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
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 28
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