510(k) K014162
K014162 is an FDA 510(k) premarket notification submitted by Lobob Laboratories, Inc. for the device "MODIFICATION TO OPTIMUM CLEANING, DISINFECTING AND". The FDA issued a decision of Substantially Equivalent on January 15, 2002. The device falls under product code MRC (Products, Contact Lens Care, Rigid Gas Permeable), a Class II device regulated under 21 CFR 886.5918. Lobob Laboratories, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 15, 2002
- Date Received
- December 19, 2001
- Clearance Type
- Special
- 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