The following data is part of a premarket notification filed by Kasios Biomaterials with the FDA for Kasios Tcp.
| Device ID | K042340 |
| 510k Number | K042340 |
| Device Name: | KASIOS TCP |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | KASIOS BIOMATERIALS 45900 PARSIPPANY COURT Temecula, CA 92592 |
| Contact | Laetita Bernard |
| Correspondent | Laetita Bernard KASIOS BIOMATERIALS 45900 PARSIPPANY COURT Temecula, CA 92592 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-30 |
| Decision Date | 2004-11-24 |
| Summary: | summary |