Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K870807 |
Device Name |
BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE |
Applicant |
ALLERGAN, INC. |
POST OFFICE BOX 25155 |
SANTA ANA,
CA
92799
|
|
Applicant Contact |
PAUL S KRAMSKY |
Correspondent |
ALLERGAN, INC. |
POST OFFICE BOX 25155 |
SANTA ANA,
CA
92799
|
|
Correspondent Contact |
PAUL S KRAMSKY |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 02/27/1987 |
Decision Date | 05/29/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|