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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 K032986
Device Name CLO-SURPLUSP.A.D.
Applicant
Scion Cardio-Vascular, Inc.
14256 SW 119 Ave.
Miami,  FL  33186
Applicant Contact RAMON AUGUSTO PAZ
Correspondent
Scion Cardio-Vascular, Inc.
14256 SW 119 Ave.
Miami,  FL  33186
Correspondent Contact RAMON AUGUSTO PAZ
Classification Product Code
QSY  
Subsequent Product Code
LYA  
Date Received09/24/2003
Decision Date 03/01/2004
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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