Device Classification Name |
Electrode, Corneal
|
510(k) Number |
K913239 |
Device Name |
GOLDLENS(TM) |
Applicant |
DORAN INSTRUMENTS, INC. |
410 GREAT RD. |
P.O. BOX 1070 |
LITTLETON,
MA
01460
|
|
Applicant Contact |
BRUCE DORAN |
Correspondent |
DORAN INSTRUMENTS, INC. |
410 GREAT RD. |
P.O. BOX 1070 |
LITTLETON,
MA
01460
|
|
Correspondent Contact |
BRUCE DORAN |
Regulation Number | 886.1220
|
Classification Product Code |
|
Date Received | 07/22/1991 |
Decision Date | 01/31/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|