KSEA CLEARVISION II, MODEL 40334120


Device Classification Name

endoscope, neurological

510(k) Number K072410
Device Name KSEA CLEARVISION II, MODEL 40334120
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

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

Correspodent Contact crystal dizol
Regulation Number 882.1480
Classification Product Code
GWG  
Date Received 08/27/2007
Decision Date 05/09/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No