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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 K140931
Device Name IGROW II HAIR GROWTH SYSTEM
Applicant
APIRA SCIENCE, INC.
641 SHUNPIKE RD, STE 311
CHATHAM,  NJ  07928
Applicant Contact RAYMAND R BLANCHE
Correspondent
APIRA SCIENCE, INC.
641 SHUNPIKE RD, STE 311
CHATHAM,  NJ  07928
Correspondent Contact RAYMAND R BLANCHE
Regulation Number890.5500
Classification Product Code
OAP  
Date Received04/11/2014
Decision Date 12/05/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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