510(k) K964902
K964902 is an FDA 510(k) premarket notification submitted by Metro Optics Of Austin, Inc. for the device "CONTACT LENSES METRO-G 3X (HIOXIFILCON B)". The FDA issued a decision of Substantially Equivalent on Mar 11, 1997. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Metro Optics Of Austin, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 11, 1997
- Date Received
- Dec 6, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Lenses, Soft Contact, Daily Wear
- Device Class
- Class II
- Regulation Number
- 886.5925
- Review Panel
- OP
- Submission Type