Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K014000 |
Device Name |
VISTITOME 20-10 MICROKERATOME |
Applicant |
BIOVISION AG |
27 MAUCHLY, UNIT 206 |
IRVINE,
CA
92618
|
|
Applicant Contact |
DAVID S FERNQUIST |
Correspondent |
BIOVISION AG |
27 MAUCHLY, UNIT 206 |
IRVINE,
CA
92618
|
|
Correspondent Contact |
DAVID S FERNQUIST |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 12/04/2001 |
Decision Date | 03/11/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|