510(k) K863943
K863943 is an FDA 510(k) premarket notification submitted by Porex Medical for the device "POREX(TM) EYE SPHERE IMPLANT". The FDA issued a decision of Substantially Equivalent on February 27, 1987. The device falls under product code HPZ (Implant, Eye Sphere), a Class II device regulated under 21 CFR 886.3320. Porex Medical has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 1987
- Date Received
- October 10, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Eye Sphere
- Device Class
- Class II
- Regulation Number
- 886.3320
- Review Panel
- OP
- Submission Type