The following data is part of a premarket notification filed by Ceremed Inc. with the FDA for Aoc Bone Wax.
| Device ID | K041363 |
| 510k Number | K041363 |
| Device Name: | AOC BONE WAX |
| Classification | Wax, Bone |
| Applicant | CEREMED INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Contact | Tadeusz Wekkusz Md |
| Correspondent | Tadeusz Wekkusz Md CEREMED INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Product Code | MTJ |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-05-21 |
| Decision Date | 2004-07-27 |
| Summary: | summary |