The following data is part of a premarket notification filed by Katecho, Inc. with the FDA for K-apatite 20-40 Mesh K-apatite 40-60.
| Device ID | K843557 |
| 510k Number | K843557 |
| Device Name: | K-APATITE 20-40 MESH K-APATITE 40-60 |
| Classification | Implant, Subperiosteal |
| Applicant | KATECHO, INC. 2302 SW 9TH. STREET Des Moines , IA 50315 - |
| Contact | Lorne Scharnberg |
| Correspondent | Lorne Scharnberg KATECHO, INC. 2302 SW 9TH. STREET Des Moines , IA 50315 - |
| Product Code | ELE |
| CFR Regulation Number | 872.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-09-10 |
| Decision Date | 1984-11-30 |