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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 K193392
Device Name BioSiCar Silicone Implant
Applicant
Metalware Technology Corp.
10f, # 117, Minquan Rd., Xindian Dist.
New Taipei City,  TW 231
Applicant Contact Megan Chang
Correspondent
Metalware Technology Corp.
10f, # 117, Minquan Rd., Xindian Dist.
New Taipei City,  TW 231
Correspondent Contact Megan Chang
Regulation Number874.3620
Classification Product Code
MIB  
Subsequent Product Codes
FWP   LZK  
Date Received12/06/2019
Decision Date 07/20/2020
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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