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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tape And Bandage, Adhesive
510(k) Number K844463
Device Name DERMIDRESS
Applicant
Kells Medical, Inc.
136 Shore Dr.
Burr Ridge,  IL  60521
Applicant Contact JOHN P SWEENEY
Correspondent
Kells Medical, Inc.
136 Shore Dr.
Burr Ridge,  IL  60521
Correspondent Contact JOHN P SWEENEY
Regulation Number880.5240
Classification Product Code
KGX  
Date Received11/20/1984
Decision Date 01/08/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
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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