Device Classification Name |
Kit, Nephroscope
|
510(k) Number |
K922826 |
Device Name |
FLEXIBLE FIBER OPTIC ENDOSCOPE |
Applicant |
OPTIMED TECHNOLOGIES, INC. |
2440 N. GLASSELL ST. |
SUITE J |
ORANGE,
CA
92665
|
|
Applicant Contact |
RONALD J EHMSEN |
Correspondent |
OPTIMED TECHNOLOGIES, INC. |
2440 N. GLASSELL ST. |
SUITE J |
ORANGE,
CA
92665
|
|
Correspondent Contact |
RONALD J EHMSEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 06/11/1992 |
Decision Date | 02/19/1993 |
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
|
|
|