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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 K872795
Device Name CHANGE IN STERILITY TEST METHOD & TEST LAB. SITE
Applicant
Medex, Inc.
6250 Shier Rings Rd.
Dublin,  OH  40316
Applicant Contact CLINT LAWSON
Correspondent
Medex, Inc.
6250 Shier Rings Rd.
Dublin,  OH  40316
Correspondent Contact CLINT LAWSON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/08/1987
Decision Date 09/04/1987
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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