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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 K130245
Device Name LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK/LARGE BORE STOPCOCK WITH EXTENSION SET, GANG LARGE BORE STOPCOCK MANIFO
Applicant
BAXTER HEALTHCARE CORP.
32650 N WILSON RD.
ROUND LAKE,  IL  60073 -0490
Applicant Contact NANETTE HEDDEN
Correspondent
BAXTER HEALTHCARE CORP.
32650 N WILSON RD.
ROUND LAKE,  IL  60073 -0490
Correspondent Contact NANETTE HEDDEN
Regulation Number880.5440
Classification Product Code
FMG  
Subsequent Product Code
FPA  
Date Received01/31/2013
Decision Date 03/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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