PEDIATRIC EXTEN. SET FOR SECOND-DRUG

Stopcock, I.v. Set

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Pediatric Exten. Set For Second-drug.

Pre-market Notification Details

Device IDK830198
510k NumberK830198
Device Name:PEDIATRIC EXTEN. SET FOR SECOND-DRUG
ClassificationStopcock, I.v. Set
Applicant TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFMG  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-01-20
Decision Date1983-02-07

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