Device Classification Name |
Keratome, Ac-Powered
|
510(k) Number |
K033236 |
Device Name |
PRIZM KERATOME BLADE, MODEL MK8512M2 |
Applicant |
SURGIN SURGICAL INSTRUMENTATION, INC. |
14762 BENTLEY CIRCLE |
TUSTIN,
CA
92680
|
|
Applicant Contact |
DON HAAR |
Correspondent |
SURGIN SURGICAL INSTRUMENTATION, INC. |
14762 BENTLEY CIRCLE |
TUSTIN,
CA
92680
|
|
Correspondent Contact |
DON HAAR |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 10/06/2003 |
Decision Date | 03/26/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|