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FDA 510(k) Application Details - K183662
Device Classification Name
Dressing, Wound, Drug
More FDA Info for this Device
510(K) Number
K183662
Device Name
Dressing, Wound, Drug
Applicant
Ascent Consumer Products, Inc.
105 Baylis Road
Melville, NY 11747 US
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Contact
Matthew Kornberg
Other 510(k) Applications for this Contact
Regulation Number
000.0000
More FDA Info for this Regulation Number
Classification Product Code
FRO
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More FDA Info for this Product Code
Date Received
12/27/2018
Decision Date
09/12/2019
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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