KARL STORZ INTUBATION FIBERSCOPE


Device Classification Name

bronchoscope (flexible or rigid)

510(k) Number K961178
Device Name KARL STORZ INTUBATION FIBERSCOPE
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Applicant Contact renate a maclaren
Correspondent
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

Correspodent Contact renate a maclaren
Regulation Number 874.4680
Classification Product Code
EOQ  
Date Received 03/26/1996
Decision Date 05/14/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No