FDA 510(k) Application Details - K192552

Device Classification Name Laser, Comb, Hair

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510(K) Number K192552
Device Name Laser, Comb, Hair
Applicant Chongqing Peninsula Medical Technology Co., Ltd.
No.2-4, 2F BLK1, Biological and Biochemical Park,
70-1 & 70-2# Ke Yuan 4 RD
Jiulongpo District 404100 CN
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Contact Zhang Sudi
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 09/17/2019
Decision Date 04/17/2020
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



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