510(k) K962711
K962711 is an FDA 510(k) premarket notification submitted by Gelflex Laboratories for the device "GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS". The FDA issued a decision of Substantially Equivalent on Sep 5, 1996. The device falls under product code LPL (Lenses, Soft Contact, Daily Wear), a Class II device regulated under 21 CFR 886.5925. Gelflex Laboratories has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 5, 1996
- Date Received
- Jun 10, 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
- 510(k)