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510(k) Data Aggregation
K Number
K981850Device Name
SILIMED CHIN IMPLANTSManufacturer
Date Cleared
1998-07-09
(44 days)
Product Code
Regulation Number
878.3550Type
TraditionalReference & Predicate Devices
N/A
Why did this record match?
Device Name :
SILIMED CHIN IMPLANTS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Silimed Chin Implants are intended for use in aesthetic, corrective or reconstructive surgery of the chin.
Device Description
Not Found
AI/ML Overview
This document is a 510(k) clearance letter from the FDA for Silimed Chin Implants, dated July 9, 1998. It primarily addresses the regulatory approval process and doesn't contain information about acceptance criteria or performance studies for the device. Therefore, I cannot provide the requested information.
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