FDA 510(k) Application Details - K240472

Device Classification Name Laser, Comb, Hair

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510(K) Number K240472
Device Name Laser, Comb, Hair
Applicant Dongguan Tutamen Metalwork Co., Ltd
No.3, Huangguotang Road
Tangxia Town
DongGuan 523000 CN
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Contact Stephen Prior
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 02/20/2024
Decision Date 10/11/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K240472


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