MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX— 510(k) K030460

Name: FDA 510(k) clearance K030460
Creator: U.S. Food and Drug Administration
Published: 2003-03-07

Substantially Equivalent

Brennen Medical, Inc.

FDA 510(k) clearance K030460 for MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX, Substantially Equivalent on 2003-03-07. Applicant: Brennen Medical, Inc.. Device class: 2.

Clearance details

Applicant: Brennen Medical, Inc.
Product code: Code PAG
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2003-02-12
Decision date: 2003-03-07
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

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