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FDA 510(k) Application Details - K160285
Device Classification Name
Laser, Comb, Hair
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510(K) Number
K160285
Device Name
Laser, Comb, Hair
Applicant
CAPILLUS, LLC
1715 NW 82nd AVE
MIAMI, FL 33126 US
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Contact
PATRICIA SCHNOOR
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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
02/03/2016
Decision Date
04/25/2016
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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