Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K010260 |
Device Name |
HANSATOME MICROKERATOME |
Applicant |
BAUSCH & LOMB, INC. |
9342 JERONIMO RD. |
IRVINE,
CA
92618
|
|
Applicant Contact |
PAUL S KRAMSKY |
Correspondent |
BAUSCH & LOMB, INC. |
9342 JERONIMO RD. |
IRVINE,
CA
92618
|
|
Correspondent Contact |
PAUL S KRAMSKY |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 01/29/2001 |
Decision Date | 04/27/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|