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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, drug
510(k) Number K803114
Device Name HYPERALIMENTATION DRESSING CHANGE TRAY
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
Classification Product Code
FRO  
Date Received12/10/1980
Decision Date 12/22/1980
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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