IMC BLOOD COLLECTION NEEDLE


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K110656
Device Name IMC BLOOD COLLECTION NEEDLE
Applicant
INTERNATIONAL MEDSURG CONNECTION
935 n plum grove road
suite f
schaumburg, 
IL 
60173

Applicant Contact peter kim
Correspondent
INTERNATIONAL MEDSURG CONNECTION
935 n plum grove road
suite f
schaumburg, 
IL 
60173

Correspodent Contact peter kim
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 03/07/2011
Decision Date 08/18/2011
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