510(k) K002586
K002586 is an FDA 510(k) premarket notification submitted by Porex Surgical Products Group for the device "MEDPOR PTERIONAL SURGICAL IMPLANT". The FDA issued a decision of Substantially Equivalent on November 17, 2000. The device falls under product code MNF (Implant, Temporal), a Class II device regulated under 21 CFR 878.3550.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 2000
- Date Received
- August 21, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Temporal
- Device Class
- Class II
- Regulation Number
- 878.3550
- Review Panel
- SU
- Submission Type