Device Classification Name |
laser, ophthalmic
|
510(k) Number |
K905141 |
Device Name |
CENTAURI |
Applicant |
PFIZER LASER SYSTEMS |
3 MORGAN |
IRVINE,
CA
92718
|
|
Applicant Contact |
COLETTE COZEAN |
Correspondent |
PFIZER LASER SYSTEMS |
3 MORGAN |
IRVINE,
CA
92718
|
|
Correspondent Contact |
COLETTE COZEAN |
Regulation Number | 886.4390
|
Classification Product Code |
|
Date Received | 11/15/1990 |
Decision Date | 02/11/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|