FLO-GARD 8500 MICROINFUSION PUMP

Pump, Infusion

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Flo-gard 8500 Microinfusion Pump.

Pre-market Notification Details

Device IDK832166
510k NumberK832166
Device Name:FLO-GARD 8500 MICROINFUSION PUMP
ClassificationPump, Infusion
Applicant TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFRN  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-05
Decision Date1983-08-16

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