PERIPHERAL INTERVENOUS CATHETER

Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

MEDICAL PROFILES, INC.

The following data is part of a premarket notification filed by Medical Profiles, Inc. with the FDA for Peripheral Intervenous Catheter.

Pre-market Notification Details

Device IDK914378
510k NumberK914378
Device Name:PERIPHERAL INTERVENOUS CATHETER
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant MEDICAL PROFILES, INC. 13324 FARMINGTON RD. Lavonia,  MI  48150
ContactMichael Mcavenia
CorrespondentMichael Mcavenia
MEDICAL PROFILES, INC. 13324 FARMINGTON RD. Lavonia,  MI  48150
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-01
Decision Date1993-05-20

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