ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9

Catheter, Nephrostomy

ZCV ,INC.

The following data is part of a premarket notification filed by Zcv ,inc. with the FDA for Zynergy Lock-sure Single Pass Drainage Catheter, Z10005/7/9.

Pre-market Notification Details

Device IDK990689
510k NumberK990689
Device Name:ZYNERGY LOCK-SURE SINGLE PASS DRAINAGE CATHETER, Z10005/7/9
ClassificationCatheter, Nephrostomy
Applicant ZCV ,INC. 298 FERNWOOD AVE. Edison,  NJ  08837
ContactPriscilla Whitehead Cox
CorrespondentPriscilla Whitehead Cox
ZCV ,INC. 298 FERNWOOD AVE. Edison,  NJ  08837
Product CodeLJE  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-03
Decision Date1999-09-03
Summary:summary

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