Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K052891 |
Device Name |
HORIZON EPIKERATOME DISPOSABLE MICROKERATOME SYSTEM |
Applicant |
HAWKEN INDUSTRIES |
377 ROUTE 17 S |
HASBROUCK HEIGHTS,
NJ
07604
|
|
Applicant Contact |
GEORGE MYERS |
Correspondent |
HAWKEN INDUSTRIES |
377 ROUTE 17 S |
HASBROUCK HEIGHTS,
NJ
07604
|
|
Correspondent Contact |
GEORGE MYERS |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 10/13/2005 |
Decision Date | 03/23/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|