FDA 510(k) Application Details - K141567

Device Classification Name Laser, Comb, Hair

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510(K) Number K141567
Device Name Laser, Comb, Hair
Applicant APIRA SCIENCE, INC.
641 SHUNPIKE RD, STE 311
CHATHAM, NJ 07928 US
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Contact RAYMOND R BLANCHE
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 06/12/2014
Decision Date 08/21/2014
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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