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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 K240472
Device Name PBM Hair Therapy Cap
Applicant
Dongguan Tutamen Metalwork Co., Ltd
No.3, Huangguotang Road
Tangxia Town
DongGuan,  CN 523000
Applicant Contact Stephen Prior
Correspondent
Dongguan Tutamen Metalwork Co., Ltd
No.3, Huangguotang Road
Tangxia Town
DongGuan,  CN 523000
Correspondent Contact Caitlyn Dzhafarov
Regulation Number890.5500
Classification Product Code
OAP  
Date Received02/20/2024
Decision Date 10/11/2024
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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