The following data is part of a premarket notification filed by Ceremed, Inc. with the FDA for Biopor, Aoc Porous Polyethylene, Cerepor.
| Device ID | K160988 |
| 510k Number | K160988 |
| Device Name: | Biopor, AOC Porous Polyethylene, Cerepor |
| Classification | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction |
| Applicant | CEREMED, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Contact | Chelsea Mitchell |
| Correspondent | Chelsea Mitchell CEREMED, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Product Code | KKY |
| CFR Regulation Number | 878.3500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-08 |
| Decision Date | 2016-07-14 |
| Summary: | summary |