The following data is part of a premarket notification filed by Sargon Ent., Inc. with the FDA for Sargon Immediate Load Implant, Model D.
| Device ID | K981141 |
| 510k Number | K981141 |
| Device Name: | SARGON IMMEDIATE LOAD IMPLANT, MODEL D |
| 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 | 1998-03-30 |
| Decision Date | 1999-06-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852550007233 | K981141 | 000 |
| 00852550007226 | K981141 | 000 |
| 00852550007219 | K981141 | 000 |
| 00852550007202 | K981141 | 000 |
| 00852550007196 | K981141 | 000 |
| 00852550007189 | K981141 | 000 |
| 00852550007172 | K981141 | 000 |
| 00852550007165 | K981141 | 000 |