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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 K920588
Device Name AVI MODEL 3000 INFUSION PUMP
Applicant
3M Health Care, Ltd.
3m Center, Bldg. 275-3e-08
P.O. Box 33275
St. Paul,  MN  55133
Applicant Contact STANLEY J SUEDKAMP
Correspondent
3M Health Care, Ltd.
3m Center, Bldg. 275-3e-08
P.O. Box 33275
St. Paul,  MN  55133
Correspondent Contact STANLEY J SUEDKAMP
Regulation Number880.5725
Classification Product Code
FRN  
Date Received02/10/1992
Decision Date 04/06/1992
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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