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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name laser, comb, hair
510(K) Number K122248
Model IGROW II HAIR GROWTH SYSTEM
Device Name IGROW II HAIR GROWTH SYSTEM
Applicant
APIRA SCIENCE, INC.
641 shunpike rd, ste 311
chatham,  NJ  07928
Contact raymond r blanche
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/27/2012
Decision Date 12/05/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Clinical Trials NCT01437163
Reviewed by Third Party No
Expedited Review No
Combination Product No
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