The following data is part of a premarket notification filed by Ceremed, Inc. with the FDA for Ostene Ct, Aoc Ct, Osteotene, Ceretene.
| Device ID | K102071 |
| 510k Number | K102071 |
| Device Name: | OSTENE CT, AOC CT, OSTEOTENE, CERETENE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-23 |
| Decision Date | 2010-10-08 |
| Summary: | summary |