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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Container, Sharps
510(k) Number K950340
Device Name IGHT AND ELEVEN GALLON SHARPS AND CHEMOTHERAPY CONTAINERS
Applicant
Bemis Mfg. Co.
300 Mill St.
P.O. Box 901
Sheboygan Falls,  WI  53085
Applicant Contact JOHN B HOWELL
Correspondent
Bemis Mfg. Co.
300 Mill St.
P.O. Box 901
Sheboygan Falls,  WI  53085
Correspondent Contact JOHN B HOWELL
Regulation Number880.5570
Classification Product Code
MMK  
Date Received01/27/1995
Decision Date 06/02/1995
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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