Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Elastomer, Silicone Block
510(k) Number K193392
Device Name BioSiCar Silicone Implant
Applicant
Metalware Technology Corp.
10F, No. 117, Minquan Rd., Xindian Dist.
New Taipei City,  TW 231
Applicant Contact Megan Chang
Correspondent
Metalware Technology Corp.
10F, No. 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
-
-