PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID

Introducer, Catheter

UNIVERSAL MEDICAL INSTRUMENT CORP.

The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Percutaneous Catheter Introducer W/cath-seal & Sid.

Pre-market Notification Details

Device IDK850820
510k NumberK850820
Device Name:PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID
ClassificationIntroducer, Catheter
Applicant UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa,  NY  12020
ContactCharles M Cooperber
CorrespondentCharles M Cooperber
UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa,  NY  12020
Product CodeDYB  
CFR Regulation Number870.1340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-28
Decision Date1985-04-10

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