Device Classification Name |
Laser, Ophthalmic
|
510(k) Number |
K881494 |
Device Name |
FOUR MODIFICATIONS TO OPHTHALAS ARGON/DYE LASER |
Applicant |
BIOPHYSIC MEDICAL, INC. |
2440 ESTAND WAY |
PLEASANT HILL,
CA
94523
|
|
Applicant Contact |
DOUGLAS DONALDSON |
Correspondent |
BIOPHYSIC MEDICAL, INC. |
2440 ESTAND WAY |
PLEASANT HILL,
CA
94523
|
|
Correspondent Contact |
DOUGLAS DONALDSON |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 04/08/1988 |
Decision Date | 08/30/1988 |
Decision |
SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS
(SN) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|