The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Microflow Irrigation System.
| Device ID | K950078 |
| 510k Number | K950078 |
| Device Name: | MICROFLOW IRRIGATION SYSTEM |
| Classification | Irrigator, Powered Nasal |
| Applicant | JEDMED INSTRUMENT CO. 6096 LEMAY FERRY RD. St.louis, MO 63129 -2217 |
| Contact | Craig R Parks |
| Correspondent | Craig R Parks JEDMED INSTRUMENT CO. 6096 LEMAY FERRY RD. St.louis, MO 63129 -2217 |
| Product Code | KMA |
| CFR Regulation Number | 874.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-01-10 |
| Decision Date | 1995-06-21 |