MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K073122
Device Name MONOJECT HYPODERMIC NEEDLE, MODEL 250, 30 GAUGE HYPODERMIC NEEDLE
Applicant
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR
15 hampshire st.
mansfield, 
MA 
02048

Applicant Contact debora stapleton
Correspondent
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR
15 hampshire st.
mansfield, 
MA 
02048

Correspodent Contact debora stapleton
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 11/06/2007
Decision Date 11/21/2007
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