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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 K843615
Device Name AVI GUARDIAN MICRO 410 INFUSION PUMP
Applicant
Avi, Inc.
1118 Red Fox Rd.
St. Paul,  MN  55112
Applicant Contact STANLEY J SUEDKAMP
Correspondent
Avi, Inc.
1118 Red Fox Rd.
St. Paul,  MN  55112
Correspondent Contact STANLEY J SUEDKAMP
Regulation Number880.5725
Classification Product Code
FRN  
Date Received09/14/1984
Decision Date 10/31/1984
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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