Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K895196 |
Device Name |
MODEL DC-1200 DIODE LASER PHOTOCOAGULATOR |
Applicant |
NIDEK, INC. |
CRC ASSOCIATES |
25422 TRABUCO ROAD#105-253 |
EL TORO,
CA
92630
|
|
Applicant Contact |
MCCOMB, PH.D. |
Correspondent |
NIDEK, INC. |
CRC ASSOCIATES |
25422 TRABUCO ROAD#105-253 |
EL TORO,
CA
92630
|
|
Correspondent Contact |
MCCOMB, PH.D. |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 08/11/1989 |
Decision Date | 10/16/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|