PICC LINE KIT

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

MEDI-FLEX HOSPITAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Medi-flex Hospital Products, Inc. with the FDA for Picc Line Kit.

Pre-market Notification Details

Device IDK952256
510k NumberK952256
Device Name:PICC LINE KIT
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant MEDI-FLEX HOSPITAL PRODUCTS, INC. 19 BUTTERFIELD TRAIL El Paso,  TX  79906
ContactOrlando Cordova
CorrespondentOrlando Cordova
MEDI-FLEX HOSPITAL PRODUCTS, INC. 19 BUTTERFIELD TRAIL El Paso,  TX  79906
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-15
Decision Date1995-07-31

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