MODEL SP5800 #8 FRENCH INTRO. KIT

Introducer, Catheter

GOULD, INC.

The following data is part of a premarket notification filed by Gould, Inc. with the FDA for Model Sp5800 #8 French Intro. Kit.

Pre-market Notification Details

Device IDK823262
510k NumberK823262
Device Name:MODEL SP5800 #8 FRENCH INTRO. KIT
ClassificationIntroducer, Catheter
Applicant GOULD, 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 Received1982-11-02
Decision Date1983-01-18

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