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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressings With Hydrocortisone
510(k) Number K883619
Device Name MEDICATED COVERING COATED W/1.0% HYDRO ADHES. GEL
Applicant
Minnetonka, Inc.
P.O. Box 1a
Minnetonka,  MN  55343
Applicant Contact RICHARD E REEVER
Correspondent
Minnetonka, Inc.
P.O. Box 1a
Minnetonka,  MN  55343
Correspondent Contact RICHARD E REEVER
Classification Product Code
SEK  
Date Received08/24/1988
Decision Date 09/01/1989
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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