BNX FINE NEEDLE ASPIRATION SYSTEM


Device Classification Name

biopsy needle kit

510(k) Number K103668
Device Name BNX FINE NEEDLE ASPIRATION SYSTEM
Applicant
BOSTON ENDOSCOPIC ENGINEERING
53 kennedy road
foster, 
RI 
02825

Applicant Contact annette m fagnant
Regulation Number 876.1075
Classification Product Code
FCG  
Date Received 12/16/2010
Decision Date 12/30/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No