IV CATHETER HUB

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

JELCO LABORATORIES

The following data is part of a premarket notification filed by Jelco Laboratories with the FDA for Iv Catheter Hub.

Pre-market Notification Details

Device IDK771381
510k NumberK771381
Device Name:IV CATHETER HUB
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant JELCO LABORATORIES 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-07-26
Decision Date1977-10-13

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