ENSIL FABRIC— 510(k) K010675

Substantially Equivalent

Gottfried Medical, Inc.

FDA 510(k) clearance K010675 for ENSIL FABRIC, Substantially Equivalent on 2001-05-30. Applicant: Gottfried Medical, Inc.. Device class: 1.

Clearance details

Applicant: Gottfried Medical, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 2001-03-06
Decision date: 2001-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toledo, OH, US

Download summary PDF View on FDA.gov ↗

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