The following data is part of a premarket notification filed by Medinvents with the FDA for Coramate/spirotome System.
| Device ID | K060384 |
| 510k Number | K060384 |
| Device Name: | CORAMATE/SPIROTOME SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | MEDINVENTS KLEIN HILLSTSTRAAT 5 Hasselt, Limburg, BE 3500 |
| Contact | Magda Buttients |
| Correspondent | Magda Buttients MEDINVENTS KLEIN HILLSTSTRAAT 5 Hasselt, Limburg, BE 3500 |
| Product Code | KNW |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-14 |
| Decision Date | 2006-07-13 |
| Summary: | summary |