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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 K073596
Device Name NEOMED SINGLE LUMEN UMBILICAL CATHETER
Applicant
Neomed, Inc.
717 Lakeglen Dr.
Swanee,  GA  30024
Applicant Contact PENNY NORTHCUTT
Correspondent
Neomed, Inc.
717 Lakeglen Dr.
Swanee,  GA  30024
Correspondent Contact PENNY NORTHCUTT
Regulation Number880.5200
Classification Product Code
FOS  
Date Received12/21/2007
Decision Date 02/22/2008
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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