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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 K003966
Device Name WUNDCATH CONDUCTION CATHETER
Applicant
Micor, Inc.
2855 Oxford Blvd.
Allison Park,  PA  15101
Applicant Contact JEREMIAH COSTELLO
Correspondent
Micor, Inc.
2855 Oxford Blvd.
Allison Park,  PA  15101
Correspondent Contact JEREMIAH COSTELLO
Regulation Number880.5725
Classification Product Code
FRN  
Date Received12/22/2000
Decision Date 07/17/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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