CATHETER CONNECTION W/INTEGRAL INJECTATE

Catheter, Intravascular, Diagnostic

GOULD, INC.

The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Catheter Connection W/integral Injectate.

Pre-market Notification Details

Device IDK830523
510k NumberK830523
Device Name:CATHETER CONNECTION W/INTEGRAL INJECTATE
ClassificationCatheter, Intravascular, Diagnostic
Applicant GOULD, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
ContactNone None
CorrespondentNone None
GOULD, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-02-17
Decision Date1983-03-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10884450330729 K830523 000
10884450330743 K830523 000
10884450361020 K830523 000
10884450330736 K830523 000

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