KEATES I/A SYSTEM FRIGITRONICS 4000

Instrument, Vitreous Aspiration And Cutting, Battery-powered

FRIGITRONICS OF CONNECTICUT, INC.

The following data is part of a premarket notification filed by Frigitronics Of Connecticut, Inc. with the FDA for Keates I/a System Frigitronics 4000.

Pre-market Notification Details

Device IDK822599
510k NumberK822599
Device Name:KEATES I/A SYSTEM FRIGITRONICS 4000
ClassificationInstrument, Vitreous Aspiration And Cutting, Battery-powered
Applicant FRIGITRONICS OF CONNECTICUT, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeHKP  
CFR Regulation Number886.4150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-08-27
Decision Date1982-10-06

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