KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522


Device Classification Name

endoscopic central control unit

510(k) Number K080410
Device Name KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Applicant Contact susie chen
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Correspodent Contact susie chen
Regulation Number 876.1500
Classification Product Code
ODA  
Date Received 02/14/2008
Decision Date 04/09/2008
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