Device Classification Name |
Light, Surgical, Fiberoptic
|
510(k) Number |
K903800 |
Device Name |
FIBER OPTIC LIGHT CABLE |
Applicant |
ORLUX ENGINEERING AND INSTRUMENTATION |
18 STRATHEARN AVENUE |
UNIT 6C |
BRAMPTON, ONTARIO,
CA
L6T 4X9
|
|
Applicant Contact |
MICHAEL TACHICH |
Correspondent |
ORLUX ENGINEERING AND INSTRUMENTATION |
18 STRATHEARN AVENUE |
UNIT 6C |
BRAMPTON, ONTARIO,
CA
L6T 4X9
|
|
Correspondent Contact |
MICHAEL TACHICH |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 08/20/1990 |
Decision Date | 08/29/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|