The following data is part of a premarket notification filed by Crospon, Ltd. with the FDA for Esoflip Es.
| Device ID | K142000 |
| 510k Number | K142000 |
| Device Name: | ESOFLIP ES |
| Classification | Esophageal Dilator With Balloon And Electrode Sensors |
| Applicant | CROSPON, LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden CROSPON, LTD. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | PIE |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-23 |
| Decision Date | 2014-09-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530810036 | K142000 | 000 |
| 20884521809441 | K142000 | 000 |