GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER

Collector, Urine, (and Accessories) For Indwelling Catheter

GENEVA LABORATORIES, INC.

The following data is part of a premarket notification filed by Geneva Laboratories, Inc. with the FDA for Gent-l-kare Sterile Urinary Drainage Bag Center.

Pre-market Notification Details

Device IDK881213
510k NumberK881213
Device Name:GENT-L-KARE STERILE URINARY DRAINAGE BAG CENTER
ClassificationCollector, Urine, (and Accessories) For Indwelling Catheter
Applicant GENEVA LABORATORIES, INC. P.O. BOX 444 Elkhorn,  WI  53121
ContactGary L Swanson
CorrespondentGary L Swanson
GENEVA LABORATORIES, INC. P.O. BOX 444 Elkhorn,  WI  53121
Product CodeKNX  
CFR Regulation Number876.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-21
Decision Date1988-07-28

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