E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE

Catheter, Nephrostomy

E-Z-EM, INC.

The following data is part of a premarket notification filed by E-z-em, Inc. with the FDA for E-z-em Single Stick Puncture/drainage.

Pre-market Notification Details

Device IDK842121
510k NumberK842121
Device Name:E-Z-EM SINGLE STICK PUNCTURE/DRAINAGE
ClassificationCatheter, Nephrostomy
Applicant E-Z-EM, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeLJE  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-29
Decision Date1984-10-01

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