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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 K220971
Device Name QuikClot Control+ Hemostatic Dressing
Applicant
Z-Medica, LLC
4 Fairfield Blvd.
Wallingford,  CT  06492
Applicant Contact Soraya King
Correspondent
Z-Medica, LLC
3015 Carrington Mill Blvd.
Suite 600
Morrisville,  NC  27560
Correspondent Contact Rachel Rehl
Regulation Number878.4454
Classification Product Code
POD  
Date Received04/04/2022
Decision Date 12/14/2022
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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