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510(k) K061892

PROPATCH SOFT TISSUE REPAIR MATRIX by Cryolife, Inc. — Product Code FTM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2006
Date Received
July 3, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Mesh, Surgical
Device Class
Class II
Regulation Number
878.3300
Review Panel
SU
Submission Type

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  • K083106 — CRYOVALVE SG PULMONARY VALVE AND CONDUIT (February 6, 2009)

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