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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name tubing, fluid delivery
510(k) Number K063114
Device Name DISPOSABLE TRANSFER SETS WITH AND WITHOUT SWABBABLE VALVES AND/OR CHECK VALVES
Applicant
COEUR, INC.
704 CADET COURT
LEBANON,  TN  37087
Applicant Contact DEBRA F MANNING
Correspondent
COEUR, INC.
704 CADET COURT
LEBANON,  TN  37087
Correspondent Contact DEBRA F MANNING
Regulation Number880.5440
Classification Product Code
FPK  
Subsequent Product Code
FPA  
Date Received10/11/2006
Decision Date 02/09/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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