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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
510(k) Number K031600
Device Name CONDUCTION CATHETER
Applicant
MICOR, INC.
2855 OXFORD BLVD.
ALLISON PARK,  PA  15101
Applicant Contact SUSAN FORGRAVE
Correspondent
MICOR, INC.
2855 OXFORD BLVD.
ALLISON PARK,  PA  15101
Correspondent Contact SUSAN FORGRAVE
Regulation Number880.5725
Classification Product Code
FRN  
Date Received05/21/2003
Decision Date 08/13/2003
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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