Device Classification Name |
Knife, Ophthalmic
|
510(k) Number |
K852633 |
Device Name |
VERSABLADE |
Applicant |
ALPHAMEDIX, INC. |
10907 NORTHRIDGE SQUARE |
CUPERTINO,
CA
95014
|
|
Applicant Contact |
CARL R JORDAN |
Correspondent |
ALPHAMEDIX, INC. |
10907 NORTHRIDGE SQUARE |
CUPERTINO,
CA
95014
|
|
Correspondent Contact |
CARL R JORDAN |
Regulation Number | 886.4350
|
Classification Product Code |
|
Date Received | 06/20/1985 |
Decision Date | 11/04/1985 |
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
|
|
|