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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, I.V.
510(k) Number K911576
Device Name CHEMOTHERAPY CONTAINER
Applicant
Bemis Mfg. Co.
300 Mill St.
Sheboygan Falls,  WI  53085
Applicant Contact JOHN B HOWELL
Correspondent
Bemis Mfg. Co.
300 Mill St.
Sheboygan Falls,  WI  53085
Correspondent Contact JOHN B HOWELL
Regulation Number880.5025
Classification Product Code
KPE  
Date Received04/08/1991
Decision Date 07/05/1991
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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