510(k) K082855
K082855 is an FDA 510(k) premarket notification submitted by Menicon Co, Ltd. for the device "MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on March 9, 2010. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Menicon Co, Ltd. has at least 10 other 510(k) clearances on record.
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