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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 K120958
Device Name POSISEP AND POSISEP X HEMOSTAT DRESSINGS
Applicant
Hemostasis, LLC
5000 Township Pkwy.
St. Paul,  MN  55110
Applicant Contact BERNARD HORWATH
Correspondent
Hemostasis, LLC
5000 Township Pkwy.
St. Paul,  MN  55110
Correspondent Contact BERNARD HORWATH
Classification Product Code
QSY  
Subsequent Product Codes
LYA   NHB  
Date Received03/30/2012
Decision Date 07/25/2012
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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