PhotoFix Decellularized Bovine Pericardium— 510(k) K183635

Substantially Equivalent

Cryolife, Inc.

FDA 510(k) clearance K183635 for PhotoFix Decellularized Bovine Pericardium, Substantially Equivalent on 2019-02-14. Applicant: Cryolife, Inc..

Clearance details

Applicant: Cryolife, Inc.
Product code: Code PSQ
Advisory panel: Cardiovascular
Date received: 2018-12-26
Decision date: 2019-02-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Kennesaw, GA, US

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