The following data is part of a premarket notification filed by Ceremed , Inc. with the FDA for Biopor Porous Polyethylene Implants.
| Device ID | K161446 |
| 510k Number | K161446 |
| Device Name: | Biopor Porous Polyethylene Implants |
| Classification | Plate, Cranioplasty, Preformed, Alterable |
| 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 | GWO |
| CFR Regulation Number | 882.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-25 |
| Decision Date | 2016-09-27 |
| Summary: | summary |