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FDA 510(k) Application Details - K240472
Device Classification Name
Laser, Comb, Hair
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
890.5500
More FDA Info for this Regulation Number
Classification Product Code
OAP
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More FDA Info for this Product Code
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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