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510(k) K193392

BioSiCar Silicone Implant by Metalware Technology Corp. — Product Code MIB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2020
Date Received
December 6, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Elastomer, Silicone Block
Device Class
Class II
Regulation Number
874.3620
Review Panel
SU
Submission Type

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