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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 K152587
Device Name DermaScalp Laser Cap
Applicant
DERMASCALP LLC
1700 ALMA DR SUITE 400
PLANO,  TX  75075
Applicant Contact JOHN CARULLO
Correspondent
DERMASCALP LLC
1700 ALMA DR SUITE 400
PLANO,  TX  75075
Correspondent Contact JOHN CARULLO
Regulation Number890.5500
Classification Product Code
OAP  
Date Received09/10/2015
Decision Date 02/04/2016
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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