Device Classification Name |
light, surgical, fiberoptic
|
510(k) Number |
K864380 |
Device Name |
LUTEX HEADLIGHT SYSTEMS |
Applicant |
LUXTEC CORP. |
P.O. BOX 225, RTE 20/49 |
TECHNO PARK RD |
STURBRIDGE,
MA
01566
|
|
Applicant Contact |
THOMAS WILK |
Correspondent |
LUXTEC CORP. |
P.O. BOX 225, RTE 20/49 |
TECHNO PARK RD |
STURBRIDGE,
MA
01566
|
|
Correspondent Contact |
THOMAS WILK |
Regulation Number | 878.4580
|
Classification Product Code |
|
Date Received | 11/05/1986 |
Decision Date | 11/19/1986 |
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
|
Recalls |
CDRH Recalls
|
|
|