The following data is part of a premarket notification filed by Ceremed, Inc. with the FDA for Aoc, Ostene, Aoc Implant Material, Ceretene, Ostene Lube, Aoc-lv.
| Device ID | K082245 |
| 510k Number | K082245 |
| Device Name: | AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | CEREMED, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Contact | Tadeusz Wellisz |
| Correspondent | Tadeusz Wellisz CEREMED, INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-07 |
| Decision Date | 2008-09-18 |
| Summary: | summary |