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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 K161875
Device Name LaserCap300, LaserCap224, LaserCap120, LaserCap80
Applicant
TRANSDERMAL CAP, INC.
938 CHESTNUT RUN
GATES MILLS,  OH  44040
Applicant Contact MICHAEL RABIN
Correspondent
TRANSDERMAL CAP, INC.
938 CHESTNUT RUN
GATES MILLS,  OH  44040
Correspondent Contact MICHAEL RABIN
Regulation Number890.5500
Classification Product Code
OAP  
Date Received07/08/2016
Decision Date 09/30/2016
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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