The following data is part of a premarket notification filed by Cordis Europa, N.v. with the FDA for Inscope 3-stage Balloon Dilator.
| Device ID | K043605 |
| 510k Number | K043605 |
| Device Name: | INSCOPE 3-STAGE BALLOON DILATOR |
| Classification | Dilator, Esophageal |
| Applicant | CORDIS EUROPA, N.V. OOSTEINDE 8 Roden, NL Nl-9301 Lj |
| Contact | Harm Hovinga |
| Correspondent | Harm Hovinga CORDIS EUROPA, N.V. OOSTEINDE 8 Roden, 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 | 2004-12-30 |
| Decision Date | 2005-02-04 |
| Summary: | summary |