KEELER KONAN SPECULAR MICROSCOPE SP5500

Microscope, Operating & Accessories, Ac-powered, Ophthalmic

KEELER INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Konan Specular Microscope Sp5500.

Pre-market Notification Details

Device IDK914956
510k NumberK914956
Device Name:KEELER KONAN SPECULAR MICROSCOPE SP5500
ClassificationMicroscope, Operating & Accessories, Ac-powered, Ophthalmic
Applicant KEELER INSTRUMENTS, INC. 456 PKWY. Broomall,  PA  19008
ContactVan Arsdale
CorrespondentVan Arsdale
KEELER INSTRUMENTS, INC. 456 PKWY. Broomall,  PA  19008
Product CodeHRM  
CFR Regulation Number878.4700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-11-05
Decision Date1992-02-03

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