I.V. START KIT

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

CARAPACE, INC.

The following data is part of a premarket notification filed by Carapace, Inc. with the FDA for I.v. Start Kit.

Pre-market Notification Details

Device IDK931729
510k NumberK931729
Device Name:I.V. START KIT
ClassificationCatheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Applicant CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow,  OK  74012
ContactJerry W Myers
CorrespondentJerry W Myers
CARAPACE, INC. 2701 W CONCORD ST. Broken Arrow,  OK  74012
Product CodeFOZ  
CFR Regulation Number880.5200 [🔎]
DecisionSubstantially Equivalent - Kit With Drugs (SEKD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-07
Decision Date1994-02-22

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