Device Classification Name |
light source, endoscope, xenon arc
|
510(k) Number |
K935423 |
Device Name |
COOL LIGHT 300 |
Applicant |
ENDOSURGICAL DEVELOPMENT CORP. |
1985 ROLLING VISTA DR. |
SUITE #52 |
LOMITA,
CA
90717
|
|
Applicant Contact |
ANTHONHY H FENDER |
Correspondent |
ENDOSURGICAL DEVELOPMENT CORP. |
1985 ROLLING VISTA DR. |
SUITE #52 |
LOMITA,
CA
90717
|
|
Correspondent Contact |
ANTHONHY H FENDER |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 11/09/1993 |
Decision Date | 01/26/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|