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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K241342
Device Name Hair Growth Comb (SZ-23,SZ-23A)
Applicant
Shenzhen Nuon Medical Equipment Co., Ltd.
1f-3f, #27-2, Xintang Rd., Xintian Comm, Fuhai St.,
Baoan Dist,
Shenzhen,  CN 518000
Applicant Contact Alain Dijkstra
Correspondent
Shenzhen Nuon Medical Equipment Co., Ltd.
1f-3f, #27-2, Xintang Rd., Xintian Comm, Fuhai St.,
Baoan Dist,
Shenzhen,  CN 518000
Correspondent Contact Alain Dijkstra
Regulation Number890.5500
Classification Product Code
OAP  
Date Received05/13/2024
Decision Date 11/08/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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