DUAL-LUMEN CATHETER


Device Classification Name

bronchoscope (flexible or rigid)

510(k) Number K024165
Device Name DUAL-LUMEN CATHETER
Original Applicant
BISTECH, INC.
5 whitcomb ave.
ayer, 
MA 
01432

Original Contact pamela papineau
Regulation Number 874.4680
Classification Product Code
EOQ  
Date Received 12/17/2002
Decision Date 01/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No