Device Classification Name |
lens, spectacle, non-custom (prescription)
|
510(k) Number |
K861021 |
Device Name |
GOTTEX SUNGLASSES |
Applicant |
PRIVATE EYES SUNGLASS CORP. |
77 ACCORD PARK DR. |
NORWELL,
MA
02061
|
|
Applicant Contact |
ELAINE BACKER |
Correspondent |
PRIVATE EYES SUNGLASS CORP. |
77 ACCORD PARK DR. |
NORWELL,
MA
02061
|
|
Correspondent Contact |
ELAINE BACKER |
Regulation Number | 886.5844
|
Classification Product Code |
|
Date Received | 03/18/1986 |
Decision Date | 06/17/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|