Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K981554 |
Device Name |
MICRATOME MS7000 -ADVANCED CORNEAL/REFRACTIVE INSTRUMENTATION (ACRI) |
Applicant |
MICRA INSTRUMENTS LTD. |
52 BILTON WAY |
LUTON,
GB
LU1 1UU
|
|
Applicant Contact |
JOHN A.K. BASKERVILLE |
Correspondent |
MICRA INSTRUMENTS LTD. |
52 BILTON WAY |
LUTON,
GB
LU1 1UU
|
|
Correspondent Contact |
JOHN A.K. BASKERVILLE |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 05/01/1998 |
Decision Date | 12/22/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|