Device Classification Name |
photocoagulator and accessories
|
510(k) Number |
K923531 |
Device Name |
OPTOSCALPEL I LASER SYSTEM |
Applicant |
OPTOMED CORP. |
8920 BUSINESS PARK DR. |
SUITE 250 |
AUSTIN,
TX
78759
|
|
Applicant Contact |
SHAHRIAR GHAFFARI |
Correspondent |
OPTOMED CORP. |
8920 BUSINESS PARK DR. |
SUITE 250 |
AUSTIN,
TX
78759
|
|
Correspondent Contact |
SHAHRIAR GHAFFARI |
Regulation Number | 886.4690
|
Classification Product Code |
|
Date Received | 07/16/1992 |
Decision Date | 11/12/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|