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FDA 510(k) Application Details - K141596
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K141596
Device Name
Laser, Comb, Hair
Applicant
NUTRA LUXE MD, LLC
5575 SANTA ROSA CT.
SPARKS, NV 89436 US
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Contact
JILL CREASY
Other 510(k) Applications for this Contact
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
06/13/2014
Decision Date
01/08/2015
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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