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K Number
K952569
Device Name
GAMP & ASSOCIATES THREE FUNCTION DISPOSABLE MANIPULATOR
Manufacturer
GAMP & ASSOC.
Date Cleared
1996-01-05

(214 days)

Product Code
HQR
Regulation Number
886.4100
Type
Traditional
Panel
OP
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 886.4100 Radiofrequency electrosurgical cautery apparatus.

(a)
Identification. A radiofrequency electrosurgical cautery apparatus is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by a high frequency electric current.(b)
Classification. Class II.