FDA 510(k) Application Details - K150792

Device Classification Name Dressing, Wound, Drug

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510(K) Number K150792
Device Name Dressing, Wound, Drug
Applicant NEXT SCIENCE, LLC
8130 BAYMEADOWS WAY WEST, SUITE 200
JACKSONVILLE, FL 33256 US
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Contact MATTHEW MYNTTI
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 03/25/2015
Decision Date 12/17/2015
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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