The following data is part of a premarket notification filed by Hohenstein Enterprises, Inc. with the FDA for Porous Hdpe Surgical Implants, To Be Distributed Under Various Trademarks Including Epor, Biopor, Minopor & P-hdpe.
| Device ID | K022665 |
| 510k Number | K022665 |
| Device Name: | POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | HOHENSTEIN ENTERPRISES, INC. 731 1/2 NORTH LABREA AVE. Los Angeles, CA 90038 |
| Contact | L. Franklin Bost |
| Correspondent | L. Franklin Bost HOHENSTEIN ENTERPRISES, INC. 731 1/2 NORTH LABREA AVE. Los Angeles, CA 90038 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-08-09 |
| Decision Date | 2002-10-09 |
| Summary: | summary |