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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hemostatic Wound Dressing Without Thrombin Or Other Biologics
510(k) Number K132105
Device Name PERCLOT TOPICAL
Applicant
Cryolife, Inc.
1655 Roberts Blvd., NW
Kennesaw,  GA  30144
Applicant Contact KIMBERLY DICONO
Correspondent
Cryolife, Inc.
1655 Roberts Blvd., NW
Kennesaw,  GA  30144
Correspondent Contact KIMBERLY DICONO
Classification Product Code
QSY  
Date Received07/08/2013
Decision Date 04/03/2014
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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