PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS


Device Classification Name

tube tracheostomy and tube cuff

510(k) Number K022212
Device Name PORTEX PERCUTANEOUS DILATATIONAL TRACHEOSTOMY KITS
Original Applicant
MENTOR MEDICAL LIMITED
military road
hythe, kent, 

GB

ct21 6db

Original Contact steve ogilvie
Regulation Number 868.5800
Classification Product Code
JOH  
Date Received 07/08/2002
Decision Date 03/21/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No