Device Classification Name |
Keratome, Ac-Powered
|
510(k) Number |
K973294 |
Device Name |
INNOVATOME MICROKERATOME |
Applicant |
INNOVATIVE OPTICS, INC. |
4307 CEDARWOOD DR. |
LILBURN,
GA
30247
|
|
Applicant Contact |
LARRY HICKS |
Correspondent |
INNOVATIVE OPTICS, INC. |
4307 CEDARWOOD DR. |
LILBURN,
GA
30247
|
|
Correspondent Contact |
LARRY HICKS |
Regulation Number | 886.4370
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/02/1997 |
Decision Date | 10/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|