The following data is part of a premarket notification filed by Villa Sistemi Medicali S.p.a. with the FDA for Endograph Dc.
| Device ID | K130109 |
| 510k Number | K130109 |
| Device Name: | ENDOGRAPH DC |
| Classification | Unit, X-ray, Extraoral With Timer |
| Applicant | VILLA SISTEMI MEDICALI S.P.A. VIADELLE AZALEE, 5 Buccinasco, Milano, IT 20090 |
| Contact | Paolo Casagrande Santin |
| Correspondent | Paolo Casagrande Santin VILLA SISTEMI MEDICALI S.P.A. VIADELLE AZALEE, 5 Buccinasco, Milano, IT 20090 |
| Product Code | EHD |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-16 |
| Decision Date | 2013-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08052870660213 | K130109 | 000 |