GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER

Catheter And Tip, Suction

PREMIUM PLASTICS, INC.

The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Gent-l-kare Ster Suct Cath Tray W/14 Fr/ster Water.

Pre-market Notification Details

Device IDK893135
510k NumberK893135
Device Name:GENT-L-KARE STER SUCT CATH TRAY W/14 FR/STER WATER
ClassificationCatheter And Tip, Suction
Applicant PREMIUM PLASTICS, INC. GENEVA LABORATORIES, INC. P.O. BOX 140, Elkhorn,  WI  53121
ContactGary L Swanson
CorrespondentGary L Swanson
PREMIUM PLASTICS, INC. GENEVA LABORATORIES, INC. P.O. BOX 140, Elkhorn,  WI  53121
Product CodeJOL  
CFR Regulation Number880.6740 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-04-25
Decision Date1989-06-22

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