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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, Occlusive
510(k) Number K861972
Device Name DERMISTRIP
Applicant
Kells Medical, Inc.
136 Shore Dr.
Burr Ridge,  IL  60521
Applicant Contact JOHN SWEENEY
Correspondent
Kells Medical, Inc.
136 Shore Dr.
Burr Ridge,  IL  60521
Correspondent Contact JOHN SWEENEY
Regulation Number878.4020
Classification Product Code
NAD  
Date Received05/21/1986
Decision Date 06/27/1986
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
Regulation Medical Specialty General & Plastic Surgery
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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