SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.)— 510(k) K021889

Name: FDA 510(k) clearance K021889
Creator: U.S. Food and Drug Administration
Published: 2002-10-16

Substantially Equivalent

Surgical Technology Laboratories, Inc.

FDA 510(k) clearance K021889 for SURGIFORM AUGMENTATION MATERIAL (S.F.A.M.), Substantially Equivalent on 2002-10-16. Applicant: Surgical Technology Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Surgical Technology Laboratories, Inc.
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 2002-06-07
Decision date: 2002-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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