The following data is part of a premarket notification filed by Cordis Europa, N.v. with the FDA for Inscope Precision Balloon Dilator - Wire Guided.
| Device ID | K060302 |
| 510k Number | K060302 |
| Device Name: | INSCOPE PRECISION BALLOON DILATOR - WIRE GUIDED |
| Classification | Dilator, Esophageal |
| Applicant | CORDIS EUROPA, N.V. OOSTEINDE 8 Roden, Drenthe, NL Nl-9301 Lj |
| Contact | Harm Hovinga |
| Correspondent | Harm Hovinga CORDIS EUROPA, N.V. OOSTEINDE 8 Roden, Drenthe, NL Nl-9301 Lj |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-06 |
| Decision Date | 2006-04-11 |
| Summary: | summary |