FDA 510(k) Application Details - K171041

Device Classification Name Dressing, Wound, Drug

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510(K) Number K171041
Device Name Dressing, Wound, Drug
Applicant Alliqua BioMedical, Inc
2150 Cabot Boulevard West
Suite B
Langhorne, PA 19047 US
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Contact Johanna Reinert
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 04/07/2017
Decision Date 08/22/2017
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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