IPI LOW PROFILE IMPORT

Port & Catheter, Implanted, Subcutaneous, Intravascular

PUDENZ-SCHULTE MEDICAL RESEARCH CORP.

The following data is part of a premarket notification filed by Pudenz-schulte Medical Research Corp. with the FDA for Ipi Low Profile Import.

Pre-market Notification Details

Device IDK934796
510k NumberK934796
Device Name:IPI LOW PROFILE IMPORT
ClassificationPort & Catheter, Implanted, Subcutaneous, Intravascular
Applicant PUDENZ-SCHULTE MEDICAL RESEARCH CORP. UNIVERSITY BUSINESS CENTER 125-B CREMONA DRIVE Goleta,  CA  93117
ContactTom Holdych
CorrespondentTom Holdych
PUDENZ-SCHULTE MEDICAL RESEARCH CORP. UNIVERSITY BUSINESS CENTER 125-B CREMONA DRIVE Goleta,  CA  93117
Product CodeLJT  
CFR Regulation Number880.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-10-06
Decision Date1994-07-14

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