KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE


Device Classification Name

endoscopic central control unit

510(k) Number K111165
Device Name KARL STORZ SCB / COVIDIEN FORCETRIAD INTERFACE MODULE
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e. grand ave.
el segundo, 
CA 
90245

Applicant Contact crystal hagan
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
2151 e. grand ave.
el segundo, 
CA 
90245

Correspodent Contact crystal hagan
Regulation Number 876.1500
Classification Product Code
ODA  
Date Received 04/26/2011
Decision Date 01/06/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Gastroenterology/Urology

510k Review Panel

Gastroenterology/Urology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No