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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Pump, Infusion
510(k) Number K812442
Device Name 3M INFUSION SYSTEM
Applicant
3M Company
8124 Pacific Ave.
White City,  OR  97503
Correspondent
3M Company
8124 Pacific Ave.
White City,  OR  97503
Regulation Number880.5725
Classification Product Code
FRN  
Date Received08/27/1981
Decision Date 09/16/1981
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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