Device Classification Name |
image, illumination, fiberoptic, for endoscope
|
510(k) Number |
K945102 |
Device Name |
MTA:ANGENIEUX STARPOINT XE XENON LIGHT SOURCE |
Applicant |
ALM SURGICAL EQUIPMENT, INC. |
1820 NORTH LEMON ST. |
ANAHEIM,
CA
92801 -1009
|
|
Applicant Contact |
SUSAN NIELSEN |
Correspondent |
ALM SURGICAL EQUIPMENT, INC. |
1820 NORTH LEMON ST. |
ANAHEIM,
CA
92801 -1009
|
|
Correspondent Contact |
SUSAN NIELSEN |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 10/18/1994 |
Decision Date | 11/04/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|