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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 K131517
Device Name MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING
Applicant
Medrad, Inc. / Bayer Medical Care, Inc.
One Medrad Dr.
Indianola,  PA  15051
Applicant Contact LISA A EWING
Correspondent
Medrad, Inc. / Bayer Medical Care, Inc.
One Medrad Dr.
Indianola,  PA  15051
Correspondent Contact LISA A EWING
Regulation Number880.5440
Classification Product Code
FPK  
Date Received05/28/2013
Decision Date 08/02/2013
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
Predetermined Change
Control Plan Authorized		 No
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