KEELER DUAL LIGHTSOURCE

Headlamp, Operating, Ac-powered

KEELER INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Keeler Instruments, Inc. with the FDA for Keeler Dual Lightsource.

Pre-market Notification Details

Device IDK861746
510k NumberK861746
Device Name:KEELER DUAL LIGHTSOURCE
ClassificationHeadlamp, Operating, Ac-powered
Applicant KEELER INSTRUMENTS, INC. 456 PKWY. Broomall,  PA  19008
ContactVan Arsdale
CorrespondentVan Arsdale
KEELER INSTRUMENTS, INC. 456 PKWY. Broomall,  PA  19008
Product CodeHPQ  
CFR Regulation Number886.4335 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-05-06
Decision Date1986-08-21

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