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FDA 510(k) Application Details - K173678
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
510(K) Number
K173678
Device Name
Laser, Comb, Hair
Applicant
Cosmo Far East Technology Limited
Room 1504, Building 1, XingJiJia Yuan, Bao'an Avenue
Songgang, Bao'an District
Shenzhen 518000 CN
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Contact
Bob An
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
11/30/2017
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
FDA Source Information for K173678
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