Device Classification Name |
choledochoscope and accessories, flexible/rigid
|
510(k) Number |
K942112 |
Device Name |
KARL STORZ FLEXIBLE CHOLEDOCHOSCOPE |
Applicant |
KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
ROBERT R GIORGINI |
Correspondent |
KARL STORZ ENDOSCOPY |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Correspondent Contact |
ROBERT R GIORGINI |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 05/02/1994 |
Decision Date | 02/28/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|