Device Classification Name |
Light Source, Fiberoptic, Routine
|
510(k) Number |
K890716 |
Device Name |
LUXTEC ACO SERIES 4000 LIGHT SOURCE |
Applicant |
LUXTEC CORP. |
P.O. BOX 225, RTE 20/49 |
TECHNO PARK RD |
STURBRIDGE,
MA
01566
|
|
Applicant Contact |
BRUCE K PACKARD |
Correspondent |
LUXTEC CORP. |
P.O. BOX 225, RTE 20/49 |
TECHNO PARK RD |
STURBRIDGE,
MA
01566
|
|
Correspondent Contact |
BRUCE K PACKARD |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 02/13/1989 |
Decision Date | 04/26/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|