Device Classification Name |
Keratome, Battery-Powered
|
510(k) Number |
K974243 |
Device Name |
KERATOME SYSTEM |
Applicant |
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. |
16 HIGGINS DR. |
MILFORD,
CT
06460
|
|
Applicant Contact |
CHARLES VASSALLO |
Correspondent |
INSIGHT TECHNOLOGIES INSTRUMENTS, LLC. |
16 HIGGINS DR. |
MILFORD,
CT
06460
|
|
Correspondent Contact |
CHARLES VASSALLO |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 11/12/1997 |
Decision Date | 01/20/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|