The following data is part of a premarket notification filed by Jedmed Instrument Co. with the FDA for Microflow Irrigation System.
| Device ID | K941356 |
| 510k Number | K941356 |
| Device Name: | MICROFLOW IRRIGATION SYSTEM |
| Classification | Catheter, Continuous Irrigation |
| Applicant | JEDMED INSTRUMENT CO. 6069 LEMAY FERRY RD. St. Louis, MO 63129 |
| Contact | Craig R Rapp |
| Correspondent | Craig R Rapp JEDMED INSTRUMENT CO. 6069 LEMAY FERRY RD. St. Louis, MO 63129 |
| Product Code | GBQ |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-21 |
| Decision Date | 1994-05-19 |