Device Classification Name |
Cystourethroscope
|
510(k) Number |
K945185 |
Device Name |
CYSTOSCOPE (78FAJ)ENDOSCOPE,FIBEROPTIC (78GDB) |
Applicant |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
600 CORPORATE POINTE |
CULVER CITY,
CA
90230 -7600
|
|
Applicant Contact |
MARIKA ANDERSON |
Correspondent |
Karl Storz Endoscopy- America, Inc. |
2151 East Grand Avenue |
El Segundo,
CA
90245
|
|
Correspondent Contact |
Leigh Spotten |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/24/1994 |
Decision Date | 05/03/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|