The following data is part of a premarket notification filed by Graphic Controls Corp. with the FDA for Medi-trace Disposable Intrauterine Catheter.
| Device ID | K910742 |
| 510k Number | K910742 |
| Device Name: | MEDI-TRACE DISPOSABLE INTRAUTERINE CATHETER |
| Classification | Monitor, Pressure, Intrauterine |
| Applicant | GRAPHIC CONTROLS CORP. 189 VAN RENSSELAER ST. P.O. BOX 1274 Buffalo, NY 14240 |
| Contact | Van Dine |
| Correspondent | Van Dine 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 | 1991-02-21 |
| Decision Date | 1992-01-14 |