FDA 510(k) Application Details - K131542

Device Classification Name Dressing, Wound, Drug

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510(K) Number K131542
Device Name Dressing, Wound, Drug
Applicant Novabay Pharmaceuticals, Inc
5600 WISCONSIN AVENUE
# 509
CHEVY CHASE, MD 20815 US
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Contact PATSY J TRISLER
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 05/29/2013
Decision Date 07/24/2013
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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