The following data is part of a premarket notification filed by Sorensen Research with the FDA for Gw 35 Guide Wire.
| Device ID | K772147 |
| 510k Number | K772147 |
| Device Name: | GW 35 GUIDE WIRE |
| Classification | Set, Dialysis, Single Needle With Uni-directional Pump |
| Applicant | SORENSEN RESEARCH 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 | 1977-11-14 |
| Decision Date | 1977-11-28 |