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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stopcock, I.V. Set
510(k) Number K954970
Device Name STOPCOCK & LUER LOCK PLUG
Applicant
Medex, Inc.
6250 Shier Rings Rd.
Dublin,  OH  40316
Applicant Contact JOHN C TOOMEY
Correspondent
Medex, Inc.
6250 Shier Rings Rd.
Dublin,  OH  40316
Correspondent Contact JOHN C TOOMEY
Regulation Number880.5440
Classification Product Code
FMG  
Date Received10/30/1995
Decision Date 04/22/1996
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
Recalls CDRH Recalls
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