FDA 510(k) Application Details - K142592

Device Classification Name Dressing, Wound, Drug

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510(K) Number K142592
Device Name Dressing, Wound, Drug
Applicant SIMPLE SCIENCE, LLC
530 NORTH 3RD STREET
SUITE 310
MINNEAPOLIS, MN 55401 US
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Contact Justin Scanlan
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 09/15/2014
Decision Date 09/02/2015
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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