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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Indicator, Physical/Chemical Sterilization Process
510(k) Number K801057
Device Name 3M STEAM STERILIZATION INDICATOR
Applicant
3M Company
8124 Pacific Ave.
White City,  OR  97503
Correspondent
3M Company
8124 Pacific Ave.
White City,  OR  97503
Regulation Number880.2800
Classification Product Code
JOJ  
Date Received05/06/1980
Decision Date 06/17/1980
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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