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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bedding, Disposable, Medical
510(k) Number K802998
Device Name PATIENT CARE DISPOSABLE INFANT SHIRTS
Applicant
American Convertors Div., American Pharmaseal
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Convertors Div., American Pharmaseal
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.6060
Classification Product Code
KME  
Date Received11/25/1980
Decision Date 12/22/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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