Device Classification Name |
Implant, Eye Sphere
|
510(k) Number |
K900081 |
Device Name |
NEW ALLEN IMPLANT |
Applicant |
OCULO PLASTIK, INC. |
1170 EAST |
HENRI-BOURASSA BLVD. |
MONTREAL, QUEBEC CANADA,
CA
H2C 1G4
|
|
Applicant Contact |
JEAN-FRANCOIS DURETT |
Correspondent |
OCULO PLASTIK, INC. |
1170 EAST |
HENRI-BOURASSA BLVD. |
MONTREAL, QUEBEC CANADA,
CA
H2C 1G4
|
|
Correspondent Contact |
JEAN-FRANCOIS DURETT |
Regulation Number | 886.3320
|
Classification Product Code |
|
Date Received | 01/04/1990 |
Decision Date | 03/23/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|