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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wrap, Sterilization
510(k) Number K885019
Device Name BEMIS STERILE-CASE FOR USE W/ETHYLENE OXIDE STERI.
Applicant
BEMIS HEALTH CARE
300 MILL ST.
P.O. BOX 901
SHEBOYGAN FALLS,  WI  53085
Applicant Contact JANE M TURNER
Correspondent
BEMIS HEALTH CARE
300 MILL ST.
P.O. BOX 901
SHEBOYGAN FALLS,  WI  53085
Correspondent Contact JANE M TURNER
Regulation Number880.6850
Classification Product Code
FRG  
Date Received11/29/1988
Decision Date 01/25/1989
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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