Device Classification Name |
Keratome, Ac-Powered
|
510(k) Number |
K994015 |
Device Name |
ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508 |
Applicant |
SURGIN SURGICAL INSTRUMENTATION, INC. |
14762 BENTLEY CIRCLE |
TUSTIN,
CA
92680
|
|
Applicant Contact |
DON HARR |
Correspondent |
SURGIN SURGICAL INSTRUMENTATION, INC. |
14762 BENTLEY CIRCLE |
TUSTIN,
CA
92680
|
|
Correspondent Contact |
DON HARR |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 11/26/1999 |
Decision Date | 03/15/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|