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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 K061661
Device Name STA CATH ATTACHABLE INFISION CATHETER, MODEL STA20
Applicant
Advanced Infusion, Inc.
466 W. Arrow Hwy., Unit H
San Dimas,  CA  91773
Applicant Contact JAMES CHRISTENSEN
Correspondent
Advanced Infusion, Inc.
466 W. Arrow Hwy., Unit H
San Dimas,  CA  91773
Correspondent Contact JAMES CHRISTENSEN
Regulation Number880.5725
Classification Product Code
MEB  
Date Received06/13/2006
Decision Date 10/18/2006
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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