PERCUTANEOUS SHEATH INTRODUCER TRAY

Introducer, Catheter

PACKAGING TECHNOLOGIES, INC.

The following data is part of a premarket notification filed by Packaging Technologies, Inc. with the FDA for Percutaneous Sheath Introducer Tray.

Pre-market Notification Details

Device IDK834074
510k NumberK834074
Device Name:PERCUTANEOUS SHEATH INTRODUCER TRAY
ClassificationIntroducer, Catheter
Applicant PACKAGING TECHNOLOGIES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-11-25
Decision Date1984-03-19

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