Cleared Traditional

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

Jul 1992
Decision
153d
Days
Risk

K920796 is an FDA 510(k) clearance for the DEROYAL TRANSPARENT FILM DRESSIGN. This device is classified as a Dressing, Wound And Burn, Occlusive.

Submitted by Deroyal Industries, Inc. (Powell, US). The FDA issued a Cleared decision on July 23, 1992, 153 days after receiving the submission on February 21, 1992.

This device falls under the General & Plastic Surgery FDA review panel.

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

Device Classification

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