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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 K103245
Device Name CELSTAT
Applicant
Baxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Applicant Contact SAMUEL MATHEW
Correspondent
Baxter Healthcare Corp
1620 Waukegan Rd.
Mcgaw Park,  IL  60085
Correspondent Contact SAMUEL MATHEW
Classification Product Code
QSY  
Date Received11/02/2010
Decision Date 03/23/2011
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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