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510(k) K101587

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2010
Date Received
June 7, 2010
Clearance Type
Traditional
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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  • K110581 — PROPATCH SOFT TISSUE REPAIR MATRIX (January 10, 2012)
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  • K083106 — CRYOVALVE SG PULMONARY VALVE AND CONDUIT (February 6, 2009)
  • K033484 — HUMAN HEART VALVE, CRYOVALVE SG (February 7, 2008)

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