510(k) K022665
POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE by
Hohenstein Enterprises, Inc.
— Product Code KKY
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 9, 2002
- Date Received
- August 9, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- Device Class
- Class II
- Regulation Number
- 878.3500
- Review Panel
- SU
- Submission Type