NOVAGEL SILICONE GEL SHEETING— 510(k) K963128

Name: FDA 510(k) clearance K963128
Creator: U.S. Food and Drug Administration
Published: 1996-12-05

Substantially Equivalent

Brennen Medical, Inc.

FDA 510(k) clearance K963128 for NOVAGEL SILICONE GEL SHEETING, Substantially Equivalent on 1996-12-05. Applicant: Brennen Medical, Inc.. Device class: 1.

Clearance details

Applicant: Brennen Medical, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1996-08-12
Decision date: 1996-12-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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