HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K073188
Device Name HYPODERMIC NEEDLE-PRO EDGE SAFETY DEVICE
Applicant
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene, 
NH 
03431

Applicant Contact brian farias
Correspondent
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene, 
NH 
03431

Correspodent Contact brian farias
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 11/13/2007
Decision Date 02/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No