Device Classification Name |
lamp, surgical
|
510(k) Number |
K954263 |
Device Name |
XE-LITE |
Applicant |
OPHTHALMIC TECHNOLOGIES, INC. |
37 KODIAK CRESCENT, |
UNIT 12 |
DOWNSVIEW, ONTARIO,
CA
MEJ 3E5
|
|
Applicant Contact |
RISHARD WEITZ |
Correspondent |
OPHTHALMIC TECHNOLOGIES, INC. |
37 KODIAK CRESCENT, |
UNIT 12 |
DOWNSVIEW, ONTARIO,
CA
MEJ 3E5
|
|
Correspondent Contact |
RISHARD WEITZ |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 09/12/1995 |
Decision Date | 10/18/1995 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|