Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K894835 |
Device Name |
LASERMED* GOGGLES AND SPECTACLES |
Applicant |
GLENDALE PROTECTIVE TECHNOLOGIES, INC. |
130 CROSSWAYS PARK DR. |
WOODBURY,
NY
11797
|
|
Applicant Contact |
JOEL G KAUFMAN |
Correspondent |
GLENDALE PROTECTIVE TECHNOLOGIES, INC. |
130 CROSSWAYS PARK DR. |
WOODBURY,
NY
11797
|
|
Correspondent Contact |
JOEL G KAUFMAN |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 07/31/1989 |
Decision Date | 09/21/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|