Device Classification Name |
Cystoscope And Accessories, Flexible/Rigid
|
510(k) Number |
K935278 |
Device Name |
KARL STORZ FIXED MAGNIFICATION TELESCOPE/KARL STORZ VARIABLE MAGNIFICATION TELESCOPE |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
SUSIE S CHEN |
Correspondent |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
SUSIE S CHEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/03/1993 |
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
|
|
|