The following data is part of a premarket notification filed by Ceremed, Inc. with the FDA for Biopor Aoc Porous Polyethylene, Cerepor.
| Device ID | K141880 |
| 510k Number | K141880 |
| 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 | 2014-07-11 |
| Decision Date | 2015-04-16 |
| Summary: | summary |