NEOMED SINGLE LUMEN UMBILICAL CATHETER


Device Classification Name

catheter, umbilical artery

510(k) Number K073596
Device Name NEOMED SINGLE LUMEN UMBILICAL CATHETER
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 12/21/2007
Decision Date 02/22/2008
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