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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 K123387
Device Name QUIKCLOT HEMOSTATIC DRESSING
Applicant
Z-Medica, LLC
4 Fairfield Blvd.
Wallingford,  CT  06492
Applicant Contact SHEILA WALLIN
Correspondent
Z-Medica, LLC
4 Fairfield Blvd.
Wallingford,  CT  06492
Correspondent Contact SHEILA WALLIN
Classification Product Code
QSY  
Date Received11/02/2012
Decision Date 04/12/2013
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
Recalls CDRH Recalls
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