MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX— 510(k) K993459

Name: FDA 510(k) clearance K993459
Creator: U.S. Food and Drug Administration
Published: 1999-11-05

Substantially Equivalent

Advanced Uroscience, Inc.

FDA 510(k) clearance K993459 for MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX, Substantially Equivalent on 1999-11-05. Applicant: Advanced Uroscience, Inc.. Device class: 2.

Clearance details

Applicant: Advanced Uroscience, Inc.
Product code: Code PAG
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 1999-10-13
Decision date: 1999-11-05
Decision: Substantially Equivalent
Clearance type: Special
Location: St. Paul, MN, US

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