Device Classification Name |
Products, Contact Lens Care, Rigid Gas Permeable
|
510(k) Number |
K122273 |
Device Name |
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS |
Applicant |
MENICON CO. LTD. |
187 BALLARDVALE STREET |
SUITE 180 |
WILMINGTON,
MA
01887
|
|
Applicant Contact |
Ellen M Beucler |
Correspondent |
MENICON CO. LTD. |
187 BALLARDVALE STREET |
SUITE 180 |
WILMINGTON,
MA
01887
|
|
Correspondent Contact |
Ellen M Beucler |
Regulation Number | 886.5918
|
Classification Product Code |
|
Date Received | 07/30/2012 |
Decision Date | 01/02/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|