FDA 510(k) Application Details - K202631

Device Classification Name Laser, Comb, Hair

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510(K) Number K202631
Device Name Laser, Comb, Hair
Applicant Slinph Technologies Co., Ltd
Room 211, Building B,
1970 Cultural and Creative Industrial Park, Minzhi Street
Longhua, Shenzhen 518110 CN
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Contact Jian Zou
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 09/11/2020
Decision Date 12/08/2020
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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