NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0


Device Classification Name

catheter, umbilical artery

510(k) Number K081515
Device Name NEOMED DUAL LUMEN UMBILICAL CATHETER, MODELS S2UVC4.0, S2UVC5.0
Applicant
NEOMED, INC.
717 lakeglen dr.
suwanee, 
GA 
30024

Applicant Contact penny northcutt
Correspondent
NEOMED, INC.
717 lakeglen dr.
suwanee, 
GA 
30024

Correspodent Contact penny northcutt
Regulation Number 880.5200
Classification Product Code
FOS  
Date Received 05/30/2008
Decision Date 07/21/2008
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