DUAL PURPOSE CATHETER

Catheters, Suction, Tracheobronchial

UNIVERSAL MEDICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Universal Medical Products, Inc. with the FDA for Dual Purpose Catheter.

Pre-market Notification Details

Device IDK945994
510k NumberK945994
Device Name:DUAL PURPOSE CATHETER
ClassificationCatheters, Suction, Tracheobronchial
Applicant UNIVERSAL MEDICAL PRODUCTS, INC. 10 SCOTT ST. New Brunswick,  NJ  08901
ContactWalter Jinotti
CorrespondentWalter Jinotti
UNIVERSAL MEDICAL PRODUCTS, INC. 10 SCOTT ST. New Brunswick,  NJ  08901
Product CodeBSY  
CFR Regulation Number868.6810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-11-22
Decision Date1995-06-21

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