GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT

Dressing, Wound, Drug

PREMIUM PLASTICS, INC.

The following data is part of a premarket notification filed by Premium Plastics, Inc. with the FDA for Gent-l-kare(tm) Sterile, Pressure Sore Manage Kit.

Pre-market Notification Details

Device IDK890107
510k NumberK890107
Device Name:GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT
ClassificationDressing, Wound, Drug
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 CodeFRO  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent - With Drug (SESD)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-11
Decision Date1989-10-24

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