CPR FOLEY CAHTETER KIT

Tray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)

CUSTOM PACK RELIABILITY

The following data is part of a premarket notification filed by Custom Pack Reliability with the FDA for Cpr Foley Cahteter Kit.

Pre-market Notification Details

Device IDK960214
510k NumberK960214
Device Name:CPR FOLEY CAHTETER KIT
ClassificationTray, Catheterization, Sterile Urethral, With Or Without Catheter (kit)
Applicant CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 Orlando,  FL  32811
ContactRichard L Ellwood
CorrespondentRichard L Ellwood
CUSTOM PACK RELIABILITY 4207 VINELAND ROAD, M-1 Orlando,  FL  32811
Product CodeFCM  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-01-16
Decision Date1996-04-01

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