FDA 510(k) Application Details - K173678

Device Classification Name Laser, Comb, Hair

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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
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Regulation Number 890.5500

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Classification Product Code OAP
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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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