DIGITAL THERMOMETER KITS

Thermometer, Electronic, Clinical

ABCO DEALERS, INC.

The following data is part of a premarket notification filed by Abco Dealers, Inc. with the FDA for Digital Thermometer Kits.

Pre-market Notification Details

Device IDK905025
510k NumberK905025
Device Name:DIGITAL THERMOMETER KITS
ClassificationThermometer, Electronic, Clinical
Applicant ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee,  WI  53218 -1238
ContactMolly Petr
CorrespondentMolly Petr
ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee,  WI  53218 -1238
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-07
Decision Date1991-02-07

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