KSEA NEURO-FIBERSCOPE


information about

Device Classification Name

endoscope, neurological

510(k) Number K002788
Device Name KSEA NEURO-FIBERSCOPE
Original Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Original Contact kevin kennan
Regulation Number 882.1480
Classification Product Code
GWG  
Date Received 09/07/2000
Decision Date 10/23/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No