THERMOMETER SHEATHS

Thermometer, Electronic, Clinical

ABCO DEALERS, INC.

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

Pre-market Notification Details

Device IDK871465
510k NumberK871465
Device Name:THERMOMETER SHEATHS
ClassificationThermometer, Electronic, Clinical
Applicant ABCO DEALERS, INC. 6601 W. MILL RD. P.O. BOX 23090 Milwaukee,  WI  53218 -1238
ContactMolly Pribek
CorrespondentMolly Pribek
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 Received1987-04-14
Decision Date1987-05-11

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