MODIFICATION TO TEMNO BIOPSY NEEDLES


Device Classification Name

biopsy needle kit

510(k) Number K024120
Device Name MODIFICATION TO TEMNO BIOPSY NEEDLES
Original Applicant
ALLEGIANCE HEALTHCARE CORP.
1500 waukegan rd. mpwm-1e
mcgaw park, 
IL 
60085

Original Contact sharon nichols
Regulation Number 876.1075
Classification Product Code
FCG  
Date Received 12/16/2002
Decision Date 01/15/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No