KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE


Device Classification Name

ureteroscope and accessories, flexible/rigid

510(k) Number K960323
Device Name KARL STORZ GELET URETERO-RENOSCOPES/KARL STORZ ALKEN MOTION CONTROL DEVICE
Applicant
KARL STORZ ENDOSCOPY-AMERICA, INC.
600 corporate pointe
culver city, 
CA 
90230 -7600

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

Correspodent Contact renate a maclaren, ph.d.
Regulation Number 876.1500
Classification Product Code
FGB  
Date Received 01/23/1996
Decision Date 04/22/1996
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

Category: Uncategorized