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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, Elastomeric
510(k) Number K992551
Device Name ALPHA INFUSION PUMP
Applicant
Advanced Infusion, Inc.
6200 S. Mcclintock #6
Tempe,  AZ  85283
Applicant Contact JAMES CHRISTENSEN
Correspondent
Advanced Infusion, Inc.
6200 S. Mcclintock #6
Tempe,  AZ  85283
Correspondent Contact JAMES CHRISTENSEN
Regulation Number880.5725
Classification Product Code
MEB  
Date Received07/30/1999
Decision Date 10/27/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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