SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE


Device Classification Name

endoscopic access overtube, gastroenterology-urology

510(k) Number K080050
Device Name SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE
Applicant
SPIRUS MEDICAL, INC.
5 whitcomb avenue
ayer, 
MA 
01432

Applicant Contact pamela papineau
Correspondent
SPIRUS MEDICAL, INC.
5 whitcomb avenue
ayer, 
MA 
01432

Correspodent Contact pamela papineau
Regulation Number 876.1500
Classification Product Code
FED  
Date Received 01/08/2008
Decision Date 05/06/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No