DUAL FLOW NEEDLE

Needle, Fistula

TRAVENOL LABORATORIES, S.A.

The following data is part of a premarket notification filed by Travenol Laboratories, S.a. with the FDA for Dual Flow Needle.

Pre-market Notification Details

Device IDK832136
510k NumberK832136
Device Name:DUAL FLOW NEEDLE
ClassificationNeedle, Fistula
Applicant TRAVENOL LABORATORIES, S.A. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeFIE  
CFR Regulation Number876.5540 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-07-01
Decision Date1983-10-14

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