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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 K092552
Device Name CLO-SURPLUS P.A.D.
Applicant
Scion Cardio-Vascular, Inc.
14256 SW 119th Ave.
Miami,  FL  33186
Applicant Contact DENNIS HAMMOND
Correspondent
Scion Cardio-Vascular, Inc.
14256 SW 119th Ave.
Miami,  FL  33186
Correspondent Contact DENNIS HAMMOND
Classification Product Code
QSY  
Subsequent Product Code
LYA  
Date Received08/20/2009
Decision Date 09/04/2009
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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