HEATED INSTRUMENT BATH

Disinfectant, Medical Devices

SIMPSON/BASYE, INC.

The following data is part of a premarket notification filed by Simpson/basye, Inc. with the FDA for Heated Instrument Bath.

Pre-market Notification Details

Device IDK870276
510k NumberK870276
Device Name:HEATED INSTRUMENT BATH
ClassificationDisinfectant, Medical Devices
Applicant SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington,  DE  19804
ContactRobert A Basye
CorrespondentRobert A Basye
SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington,  DE  19804
Product CodeLRJ  
CFR Regulation Number880.6890 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-01-27
Decision Date1987-05-07

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