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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 K080210
Device Name PRO QR ADVANCED FORMULA POWDER
Applicant
Biolife, LLC
1235 Tallevast Rd.
Sarasota,  FL  34243
Applicant Contact Karen O'Toole
Correspondent
Biolife, LLC
1235 Tallevast Rd.
Sarasota,  FL  34243
Correspondent Contact Karen O'Toole
Classification Product Code
QSY  
Date Received01/28/2008
Decision Date 02/10/2009
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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