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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 K041585
Device Name AUTOFUSER AMBULATORY INFUSION PUMP
Applicant
ALGOS, LC
150 LAKE VILLAGE DRIVE
SUITE 203
ANN ARBOR,  MI  48103
Applicant Contact ROBERT J BARD
Correspondent
ALGOS, LC
150 LAKE VILLAGE DRIVE
SUITE 203
ANN ARBOR,  MI  48103
Correspondent Contact ROBERT J BARD
Regulation Number880.5725
Classification Product Code
MEB  
Date Received06/14/2004
Decision Date 08/26/2004
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
Recalls CDRH Recalls
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