The following data is part of a premarket notification filed by Core-vent Corp. with the FDA for Swede-vent Implant.
| Device ID | K950577 |
| 510k Number | K950577 |
| Device Name: | SWEDE-VENT IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | CORE-VENT CORP. 4630 SOUTH ARVILLE STE D Las Vegas, NV 89103 |
| Contact | Glen Neally |
| Correspondent | Glen Neally CORE-VENT CORP. 4630 SOUTH ARVILLE STE D Las Vegas, NV 89103 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-27 |
| Decision Date | 1995-07-11 |