The following data is part of a premarket notification filed by Sargon Ent., Inc. with the FDA for Sargon Cylindro-blade Implant.
| Device ID | K930071 |
| 510k Number | K930071 |
| Device Name: | SARGON CYLINDRO-BLADE IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | SARGON ENT., INC. 2000 M STREET, N.W. SUITE 700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli SARGON ENT., INC. 2000 M STREET, N.W. SUITE 700 Washington, DC 20036 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-06 |
| Decision Date | 1994-07-08 |