The following data is part of a premarket notification filed by Medtech Instruments with the FDA for Medtronic Instent Esophacoil Esophageal Stent System And Esophacoil Extension System.
| Device ID | K973584 |
| 510k Number | K973584 |
| Device Name: | MEDTRONIC INSTENT ESOPHACOIL ESOPHAGEAL STENT SYSTEM AND ESOPHACOIL EXTENSION SYSTEM |
| Classification | Prosthesis, Esophageal |
| Applicant | MEDTECH INSTRUMENTS 6271 BURY DR. Eden Prairie, MN 55346 |
| Contact | John R Dalpee |
| Correspondent | John R Dalpee MEDTECH INSTRUMENTS 6271 BURY DR. Eden Prairie, MN 55346 |
| Product Code | ESW |
| CFR Regulation Number | 878.3610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-22 |
| Decision Date | 1998-01-09 |
| Summary: | summary |