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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K943897
Device Name NU-SITE
Applicant
Medex, Inc.
3637 Lacon Rd.
Hilliard,  OH  43026
Applicant Contact CATHY CHENETSKI
Correspondent
Medex, Inc.
3637 Lacon Rd.
Hilliard,  OH  43026
Correspondent Contact CATHY CHENETSKI
Regulation Number880.5440
Classification Product Code
FPA  
Date Received08/10/1994
Decision Date 02/10/1995
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
Recalls CDRH Recalls
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