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FDA 510(k) Application Details - K151516
Device Classification Name
Laser, Comb, Hair
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510(K) Number
K151516
Device Name
Laser, Comb, Hair
Applicant
Capillus, LLC
1715 NW 82ND AVENUE
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
06/05/2015
Decision Date
08/21/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
PM - Physical Medicine
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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