CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER

Unit, Cryophthalmic, Ac-powered

KEELER INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Cryomatic Cryo Console, Disposable Cryo Probe, Disposable Probe Adapter.

Pre-market Notification Details

Device IDK112093
510k NumberK112093
Device Name:CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER
ClassificationUnit, Cryophthalmic, Ac-powered
Applicant KEELER INSTRUMENTS, INC. 456 PKWY. Broomall,  PA  19008
ContactEugene R Vanarsdale
CorrespondentEugene R Vanarsdale
KEELER INSTRUMENTS, INC. 456 PKWY. Broomall,  PA  19008
Product CodeHRN  
CFR Regulation Number886.4170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-22
Decision Date2011-12-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.