The following data is part of a premarket notification filed by Ceremed, Inc. with the FDA for Aoc Bone Wax, Ostene, Osteotene, Orthoseal, Osteoseal, Ceretene, Model Bw-12.
| Device ID | K050440 |
| 510k Number | K050440 |
| Device Name: | AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 |
| Classification | Wax, Bone |
| 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 | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-22 |
| Decision Date | 2005-03-24 |
| Summary: | summary |