The following data is part of a premarket notification filed by Ceremed Inc. with the FDA for Ostene, Aoc, Osteotene, Ceretene, Cerepor, Aptene, Apatene, Actipaste.
| Device ID | K070093 |
| 510k Number | K070093 |
| Device Name: | OSTENE, AOC, OSTEOTENE, CERETENE, CEREPOR, APTENE, APATENE, ACTIPASTE |
| Classification | Polymer, Ent Synthetic-polyamide (mesh Or Foil Material) |
| Applicant | CEREMED INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Contact | Tadeusz Wellisz M.d. |
| Correspondent | Tadeusz Wellisz M.d. CEREMED INC. 3643 LENAWEE AVE. Los Angeles, CA 90016 |
| Product Code | KHJ |
| CFR Regulation Number | 874.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-10 |
| Decision Date | 2007-01-24 |
| Summary: | summary |