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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 K112073
Device Name INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK...
Applicant
Rx Devices, LLC
19200 Ashville Hwy.
Landrum,  SC  29356
Applicant Contact CHARLES HOKANSON
Correspondent
Rx Devices, LLC
19200 Ashville Hwy.
Landrum,  SC  29356
Correspondent Contact CHARLES HOKANSON
Regulation Number880.5440
Classification Product Code
FPA  
Date Received07/20/2011
Decision Date 04/11/2012
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
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