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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 K173846
Device Name DermaScalp Laser Cap
Applicant
Dermascalp, LLC
190 E. Stacy Rd.
Suite 306-291
Allen,  TX  75002
Applicant Contact John Carullo
Correspondent
Dermascalp, LLC
190 E. Stacy Rd.
Suite 306-291
Allen,  TX  75002
Correspondent Contact John Carullo
Regulation Number890.5500
Classification Product Code
OAP  
Date Received12/19/2017
Decision Date 03/21/2018
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
Predetermined Change
Control Plan Authorized		 No
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