R & D BATTERIES

Ophthalmoscope, Battery-powered

R & D BATTERIES, INC.

The following data is part of a premarket notification filed by R & D Batteries, Inc. with the FDA for R & D Batteries.

Pre-market Notification Details

Device IDK936104
510k NumberK936104
Device Name:R & D BATTERIES
ClassificationOphthalmoscope, Battery-powered
Applicant R & D BATTERIES, INC. 2224 EAST 117TH ST. P.O. BOX 5007 Burnsville,  MN  55337
ContactRandall C Noddings
CorrespondentRandall C Noddings
R & D BATTERIES, INC. 2224 EAST 117TH ST. P.O. BOX 5007 Burnsville,  MN  55337
Product CodeHLJ  
CFR Regulation Number886.1570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-22
Decision Date1994-02-22

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