FDA 510(k) Application Details - K213789

Device Classification Name Laser, Comb, Hair

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510(K) Number K213789
Device Name Laser, Comb, Hair
Applicant Yibin Yingtong Intelligent Technology Co.,Ltd.
3F, Building 1, Area A, Intelligent Terminal Industrial Park
Yibin Economic Development Zone
Yibin 644000 CN
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Contact Pengcheng Pan
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 12/06/2021
Decision Date 06/24/2022
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 K213789


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