FDA 510(k) Application Details - K143466

Device Classification Name

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510(K) Number K143466
Device Name Hemogrip Patch
Applicant REMEDIUM TECHNOLOGIES, INC.
387 TECHNOLOGY DR. SUITE 3110B
COLLEGE PARK, MD 20742 US
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Contact JOHN GUSTIN
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Regulation Number

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Classification Product Code QSY
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Date Received 12/04/2014
Decision Date 06/08/2015
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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