INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE ‘Y’ ADAPTER (BULK…


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 -9021

Applicant Contact charles hokanson
Correspondent
RX DEVICES LLC
19200 ashville hwy
landrum, 
SC 
29356 -9021

Correspodent Contact charles hokanson
Regulation Number 880.5440
Classification Product Code
FPA  
Date Received 07/20/2011
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