Device Classification Name |
light source, endoscope, xenon arc
|
510(k) Number |
K953924 |
Device Name |
XLS-300 XENON LIGHT SOURCE |
Applicant |
SPECIALTIES OF SURGERY |
P.O. BOX 560 |
JENKS,
OK
74037
|
|
Applicant Contact |
JOHN NORTON |
Correspondent |
SPECIALTIES OF SURGERY |
P.O. BOX 560 |
JENKS,
OK
74037
|
|
Correspondent Contact |
JOHN NORTON |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 08/18/1995 |
Decision Date | 09/21/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|