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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K890107
Device Name GENT-L-KARE(TM) STERILE, PRESSURE SORE MANAGE KIT
Applicant
Premium Plastics, Inc.
Geneva Laboratories, Inc.
P.O. Box 140,
Elkhorn,  WI  53121
Applicant Contact GARY L SWANSON
Correspondent
Premium Plastics, Inc.
Geneva Laboratories, Inc.
P.O. Box 140,
Elkhorn,  WI  53121
Correspondent Contact GARY L SWANSON
Classification Product Code
FRO  
Date Received01/11/1989
Decision Date 10/24/1989
Decision Substantially Equivalent - With Drug (SESD)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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