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FDA 510(k) Application Details - K173729
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K173729
Device Name
Laser, Comb, Hair
Applicant
PhotonMD, Inc
627 Davis Drive, Suite 400
Morrisville, NC 27560 US
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Contact
William A Knape
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Regulation Number
890.5500
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Classification Product Code
OAP
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More FDA Info for this Product Code
Date Received
12/06/2017
Decision Date
02/28/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
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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