Cleared Traditional

K920796 - DEROYAL TRANSPARENT FILM DRESSIGN (FDA 510(k) Clearance)

K920796 · Deroyal Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1992
Decision
153d
Days
-
Risk

K920796 is an FDA 510(k) clearance for the DEROYAL TRANSPARENT FILM DRESSIGN. Classified as Dressing, Wound And Burn, Occlusive (product code MGP).

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on July 23, 1992 after a review of 153 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 Deroyal Industries, Inc. devices

Submission Details

510(k) Number K920796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1992
Decision Date July 23, 1992
Days to Decision 153 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
39d slower than avg
Panel avg: 114d · This submission: 153d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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