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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 K983634
Device Name PREPARE HOME INFUSION PUMP
Applicant
Medical Infusion Technologies, Inc.
6576 E. Quaker St.
Orchard Park,  NY  14127
Applicant Contact THOMAS L PARKER
Correspondent
Medical Infusion Technologies, Inc.
6576 E. Quaker St.
Orchard Park,  NY  14127
Correspondent Contact THOMAS L PARKER
Regulation Number880.5725
Classification Product Code
MEB  
Date Received10/15/1998
Decision Date 02/24/1999
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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