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K Number
K961071

Validate with FDA (Live)

Device Name
THE MAGNUM CHIN IMPLANT
Manufacturer
RAND SCIENTIFIC CORP.
Date Cleared
1996-04-19

(32 days)

Product Code
FWP
Regulation Number
878.3550
Type
Traditional
Panel
General & Plastic Surgery
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 878.3550 Chin prosthesis.

(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.