RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED


Device Classification Name

tube, tracheostomy (w/wo connector)

510(k) Number K021764
Device Name RUSCH TRACHEOFIX SET, CUFFED AND UNCUFFED
Original Applicant
RUSCH INTL.
tall pines park
jaffrey, 
NH 
03452

Original Contact rick lykins
Regulation Number 868.5800
Classification Product Code
BTO  
Date Received 05/29/2002
Decision Date 07/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No