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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 K162071
Device Name IllumiFlow Laser Cap
Applicant
EGLOBAL, LLC
10115 E BELL RD STE 107
SCOTTSDALE,  AZ  85260
Applicant Contact WAYNE DESTEFANO
Correspondent
LIZA BURNS AND ASSOCIATES
6469G KAWAIHAU RD
KAPAA,  HI  96746
Correspondent Contact LIZA BURNS
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/27/2016
Decision Date 02/24/2017
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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