Device Classification Name |
ureteroscope and accessories, flexible/rigid
|
510(k) Number |
K940464 |
Device Name |
KARL STORZ URETERO-RENOSCOPE/URETERSCOPE |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Applicant Contact |
JONATHAN S KAHAN |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
COLUMBIA SQUARE |
555 THIRTEENTH STREET, N.W. |
WASHINGTON,
DC
20004 -1109
|
|
Correspondent Contact |
JONATHAN S KAHAN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/02/1994 |
Decision Date | 06/24/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|