The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Endos Ac/acp.
| Device ID | K030185 |
| 510k Number | K030185 |
| Device Name: | ENDOS AC/ACP |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | VILLA SISTEMI MEDICALI S.P.A. 11550 WEST KING ST. Franklin Park, IL 60131 |
| Contact | Andrew Hryndza |
| Correspondent | Andrew Hryndza VILLA SISTEMI MEDICALI S.P.A. 11550 WEST KING ST. Franklin Park, IL 60131 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-21 |
| Decision Date | 2003-03-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052870660718 | K030185 | 000 |
| 08052870660619 | K030185 | 000 |
| 08052870660510 | K030185 | 000 |
| 08052870660411 | K030185 | 000 |
| 08052870660312 | K030185 | 000 |