510(k) K082855

MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES by Menicon Co, Ltd. — Product Code MRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 9, 2010
Date Received
September 29, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Device Class
Class II
Regulation Number
886.5918
Review Panel
OP
Submission Type