The following data is part of a premarket notification filed by Contour Fabricators, Inc. with the FDA for Cfi Ultrasound Probe Drape.
| Device ID | K090773 |
| 510k Number | K090773 |
| Device Name: | CFI ULTRASOUND PROBE DRAPE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | CONTOUR FABRICATORS, INC. 14241 FENTON RD. Fenton, MI 48430 |
| Contact | John W Schaefer |
| Correspondent | John W Schaefer CONTOUR FABRICATORS, INC. 14241 FENTON RD. Fenton, MI 48430 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-23 |
| Decision Date | 2009-09-18 |
| Summary: | summary |