Device Classification Name |
Light Source, Endoscope, Xenon Arc
|
510(k) Number |
K981804 |
Device Name |
XENON LIGHT SOURCE MODEL LS6000 |
Applicant |
CONTEC MEDICAL VISION, LTD. |
1109 STURBRIDGE RD. |
FALLSTON,
MD
21047
|
|
Applicant Contact |
ALBERT E AUSTIN |
Correspondent |
CONTEC MEDICAL VISION, LTD. |
1109 STURBRIDGE RD. |
FALLSTON,
MD
21047
|
|
Correspondent Contact |
ALBERT E AUSTIN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/21/1998 |
Decision Date | 07/24/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|