PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA


Device Classification Name

tube tracheostomy and tube cuff

510(k) Number K960429
Device Name PER-FIT PERCUTANEOUS TRACHEOSTOMY KIT W/PORTEX TRACHEOSTMY TUBE & DISP. INNER CANNULA
Applicant
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 kit st.
keene, 
NH 
03431

Applicant Contact timothy j talcott
Correspondent
SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
15 kit st.
keene, 
NH 
03431

Correspodent Contact timothy j talcott
Regulation Number 868.5800
Classification Product Code
JOH  
Date Received 01/31/1996
Decision Date 05/02/1996
Decision

substantially equivalent – kit

(SESK)

Regulation Medical Specialty

Anesthesiology

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No