The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Enthermo Irrigation Unit.
| Device ID | K863615 |
| 510k Number | K863615 |
| Device Name: | ENTHERMO IRRIGATION UNIT |
| Classification | Stimulator, Caloric-water |
| Applicant | JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Contact | Craig Rapp |
| Correspondent | Craig Rapp JEDMED INSTRUMENT CO. 1430 HANLEY INDUSTRIAL CT. St. Louis, MO 63144 |
| Product Code | ETP |
| CFR Regulation Number | 874.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-16 |
| Decision Date | 1986-12-16 |