Device Classification Name |
Light Source, Endoscope, Xenon Arc
|
510(k) Number |
K962365 |
Device Name |
XENON LIGHTSOURCE |
Applicant |
DSP WORLDWIDE |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Applicant Contact |
ROSINA ROBINSON |
Correspondent |
DSP WORLDWIDE |
49 PLAIN ST. |
NORTH ATTLEBORO,
MA
02760
|
|
Correspondent Contact |
ROSINA ROBINSON |
Regulation Number | 876.1500 |
Classification Product Code |
|
Date Received | 06/19/1996 |
Decision Date | 07/18/1996 |
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
|
Predetermined Change Control Plan Authorized |
No
|
|
|