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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 K071578
Device Name BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS-IX27, BS-IX-14, BSIX-15, BSIX-17
Applicant
Lifescience Plus, Inc.
22 Stony Hill Dr.
Mystic,  CT  06355
Applicant Contact AUDREY VITALE
Correspondent
Lifescience Plus, Inc.
22 Stony Hill Dr.
Mystic,  CT  06355
Correspondent Contact AUDREY VITALE
Classification Product Code
QSY  
Date Received06/08/2007
Decision Date 09/27/2007
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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