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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Brush, Scrub, Operating-Room
510(k) Number K803116
Device Name HEAVY DRAINAGE PACK
Applicant
American Medical Disposable, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Medical Disposable, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number878.4800
Classification Product Code
GEC  
Date Received12/10/1980
Decision Date 01/28/1981
Decision Substantially Equivalent (SESE)
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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