ELUTIA COATED CLOSED SURGICAL WOUND DRAIN— 510(k) K063245

Substantially Equivalent

Bacterin International, Inc.

FDA 510(k) clearance K063245 for ELUTIA COATED CLOSED SURGICAL WOUND DRAIN, Substantially Equivalent on 2007-11-28. Applicant: Bacterin International, Inc..

Clearance details

Applicant: Bacterin International, Inc.
Product code: Code OEI
Advisory panel: General, Plastic Surgery
Date received: 2006-10-26
Decision date: 2007-11-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

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