Device Classification Name |
keratome, ac-powered
|
510(k) Number |
K040204 |
Device Name |
ZYOPTIX XP MICROKERATOME |
Applicant |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609 -3547
|
|
Applicant Contact |
DEBRA L.B. KETCHUM |
Correspondent |
BAUSCH & LOMB, INC. |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609 -3547
|
|
Correspondent Contact |
DEBRA L.B. KETCHUM |
Regulation Number | 886.4370
|
Classification Product Code |
|
Date Received | 01/29/2004 |
Decision Date | 03/22/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|