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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 K931664
Device Name SHARPS DISPOSABLE CONTAINERS
Applicant
Bemis Mfg. Co.
300 Mill St.
Sheboygan Falls,  WI  53085
Applicant Contact JOH B HOWELL
Correspondent
Bemis Mfg. Co.
300 Mill St.
Sheboygan Falls,  WI  53085
Correspondent Contact JOH B HOWELL
Regulation Number880.5570
Classification Product Code
MMK  
Date Received04/05/1993
Decision Date 05/23/1994
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
Recalls CDRH Recalls
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