The following data is part of a premarket notification filed by Extracorporeal Medical Specialities, Inc. with the FDA for Model Dm 353 & Dm-353-l Single Needle.
| Device ID | K792174 |
| 510k Number | K792174 |
| Device Name: | MODEL DM 353 & DM-353-L SINGLE NEEDLE |
| Classification | Set, Dialysis, Single Needle With Uni-directional Pump |
| Applicant | EXTRACORPOREAL MEDICAL SPECIALITIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FIF |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-10-29 |
| Decision Date | 1979-11-16 |