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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone Block
510(k) Number K222748
Device Name ShiNeo Silicone Implant
Applicant
Shineo Technology Co., Ltd.
5f, 207-4, Xinshu Rd..,
New Taipei City,  TW 24262
Applicant Contact Wan-Chun Lai
Correspondent
Shineo Technology Co., Ltd.
5f, 207-4, Xinshu Rd..,
New Taipei City,  TW 24262
Correspondent Contact Wan-Chun Lai
Regulation Number874.3620
Classification Product Code
MIB  
Subsequent Product Codes
FWP   LZK  
Date Received09/12/2022
Decision Date 12/23/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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