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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 K143466
Device Name Hemogrip Patch
Applicant
REMEDIUM TECHNOLOGIES, INC.
387 TECHNOLOGY DR. SUITE 3110B
COLLEGE PARK,  MD  20742
Applicant Contact JOHN GUSTIN
Correspondent
REMEDIUM TECHNOLOGIES, INC.
387 TECHNOLOGY DR. SUITE 3110B
COLLEGE PARK,  MD  20742
Correspondent Contact JOHN GUSTIN
Classification Product Code
QSY  
Date Received12/04/2014
Decision Date 06/08/2015
Decision Substantially Equivalent (SESE)
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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