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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary, Internal Use Hemostatic
510(k) Number K200167
FOIA Releasable 510(k) K200167
Device Name QuikClot Control+
Applicant
Z-Medica, LLC
4 Fairfield Blvd.
Wallingford,  CT  06492
Applicant Contact Soraya King
Correspondent
Z-Medica, LLC
4 Fairfield Blvd.
Wallingford,  CT  06492
Correspondent Contact Soraya King
Regulation Number878.4454
Classification Product Code
POD  
Date Received01/23/2020
Decision Date 04/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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