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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
FOIA Releasable 510(k) K122248
Device Name IGROW II HAIR GROWTH SYSTEM
Applicant
Apira Science, Inc.
641 Shunpike Rd.
Suite 311
Chatham,  NJ  07928
Applicant Contact RAYMOND R BLANCHE
Correspondent
Apira Science, Inc.
641 Shunpike Rd.
Suite 311
Chatham,  NJ  07928
Correspondent Contact RAYMOND R BLANCHE
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/27/2012
Decision Date 12/05/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT01437163
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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