Device Classification Name |
light source, endoscope, xenon arc
|
510(k) Number |
K921390 |
Device Name |
XENON LIGHT SOURCE AND ACCESSORIES |
Applicant |
COOPERVISION SURGICAL |
15 FOREST PKWY. |
SHELTON,
CT
06484
|
|
Applicant Contact |
CLIFFORD F POTOCKY |
Correspondent |
COOPERVISION SURGICAL |
15 FOREST PKWY. |
SHELTON,
CT
06484
|
|
Correspondent Contact |
CLIFFORD F POTOCKY |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 03/23/1992 |
Decision Date | 07/27/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|