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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 K021062
Device Name CHITO-SEAL
Applicant
Abbott Vascular, Inc.
400 Saginaw Dr.
Redwood,  CA  94063
Applicant Contact SEVRINA CIUCCI
Correspondent
Abbott Vascular, Inc.
400 Saginaw Dr.
Redwood,  CA  94063
Correspondent Contact SEVRINA CIUCCI
Classification Product Code
QSY  
Date Received04/02/2002
Decision Date 08/23/2002
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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