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510(k) Data Aggregation
K Number
K981835Device Name
SILIMED MALAR IMPLANTManufacturer
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 MALAR IMPLANT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Silimed Malar Implant is designed to be used for augmentation and reconstruction of the cheek.
Device Description
Not Found
AI/ML Overview
I am sorry, but the provided text does not contain the information requested regarding acceptance criteria, device performance, study details, and ground truth establishment for a medical device. The text is a 510(k) clearance letter from the FDA for a Malar Implant, primarily discussing the regulatory approval process and general regulations. It does not include specific performance metrics, clinical study designs, or expert review details.
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