Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K852234 |
Device Name |
MDS 83 OPHTHALMIC DYE LASER SYSTEM |
Applicant |
MEDITEC, INC. |
616 E. ST. |
CLEARWATER,
FL
33516
|
|
Applicant Contact |
TONEY G HOWARD |
Correspondent |
MEDITEC, INC. |
616 E. ST. |
CLEARWATER,
FL
33516
|
|
Correspondent Contact |
TONEY G HOWARD |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 05/22/1985 |
Decision Date | 08/01/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|