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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 K831703
Device Name COVERUPS
Applicant
The Urology Group
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
The Urology Group
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4020
Classification Product Code
NAD  
Date Received05/25/1983
Decision Date 01/03/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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