The following data is part of a premarket notification filed by Medinvents with the FDA for Coramate/spirotome System.
| Device ID | K080095 |
| 510k Number | K080095 |
| Device Name: | CORAMATE/SPIROTOME SYSTEM |
| Classification | Instrument, Biopsy |
| Applicant | MEDINVENTS KLEIN HILLSTSTRAAT 5 Hasselt, Limburg, BE 3500 |
| Contact | Jaak Janssens |
| Correspondent | Jaak Janssens 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 | 2008-01-14 |
| Decision Date | 2008-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05407005000267 | K080095 | 000 |
| 05407005000120 | K080095 | 000 |
| 05407005000113 | K080095 | 000 |
| 05407005000106 | K080095 | 000 |
| 05407005000090 | K080095 | 000 |
| 05407005000083 | K080095 | 000 |
| 05407005000076 | K080095 | 000 |
| 05407005000052 | K080095 | 000 |
| 05407005000045 | K080095 | 000 |
| 05407005000038 | K080095 | 000 |
| 05407005000137 | K080095 | 000 |
| 05407005000144 | K080095 | 000 |
| 05407005000151 | K080095 | 000 |
| 05407005000250 | K080095 | 000 |
| 05407005000243 | K080095 | 000 |
| 05407005000236 | K080095 | 000 |
| 05407005000212 | K080095 | 000 |
| 05407005000205 | K080095 | 000 |
| 05407005000199 | K080095 | 000 |
| 05407005000182 | K080095 | 000 |
| 05407005000175 | K080095 | 000 |
| 05407005000168 | K080095 | 000 |
| 05407005000014 | K080095 | 000 |