Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K020079 |
Device Name |
BLADEWORKS MICROKERATOME BLADE, MODEL 7061 |
Applicant |
BLADE WORKS, INC. |
1816 TOWHEE ST. |
SAN MARCOS,
CA
92069
|
|
Applicant Contact |
MARK MOYER |
Correspondent |
BLADE WORKS, INC. |
1816 TOWHEE ST. |
SAN MARCOS,
CA
92069
|
|
Correspondent Contact |
MARK MOYER |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 01/10/2002 |
Decision Date | 04/19/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|