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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Umbilical Artery
510(k) Number K840339
Device Name UMBILICAL VESSEL CATHETER
Applicant
Catheter Technology Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Catheter Technology Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number880.5200
Classification Product Code
FOS  
Date Received01/25/1984
Decision Date 07/25/1984
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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