BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST


Device Classification Name

needle, hypodermic, single lumen

510(k) Number K022415
Device Name BONE INJECTION GUN (B.I.G.) FOR PEDIATRICS, MODEL 1ST
Original Applicant
WAISMED LTD.
117 ahuzah st
ra’ananna, 

IL

Original Contact dorit winitz
Regulation Number 880.5570
Classification Product Code
FMI  
Date Received 07/24/2002
Decision Date 10/11/2002
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