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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 K042246
Device Name MULTI-DRIP INFUSION CATHETER
Applicant
ADVANCED INFUSION, INC.
6200 SOUTH MCCLINTOCK #6
TEMPE,  AZ  85283
Applicant Contact JAMES CHRISTENSEN
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact NED DEVINE
Regulation Number880.5725
Classification Product Code
MEB  
Date Received08/19/2004
Decision Date 08/31/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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