The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Softrans Plus Intrauterine Pressure Catheter System (iup 5000, Softrans Plus Iupc).
| Device ID | K974730 |
| 510k Number | K974730 |
| Device Name: | SOFTRANS PLUS INTRAUTERINE PRESSURE CATHETER SYSTEM (IUP 5000, SOFTRANS PLUS IUPC) |
| Classification | Monitor, Pressure, Intrauterine |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Contact | Kathleen H Selover |
| Correspondent | Kathleen H Selover GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Product Code | KXO |
| CFR Regulation Number | 884.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-18 |
| Decision Date | 1998-07-14 |
| Summary: | summary |