The following data is part of a premarket notification filed by Wright Medical Corp. with the FDA for Wright Medical Fetasafe.
| Device ID | K892501 |
| 510k Number | K892501 |
| Device Name: | WRIGHT MEDICAL FETASAFE |
| Classification | System, Monitoring, Perinatal |
| Applicant | WRIGHT MEDICAL CORP. 11023 118TH PLACE N.E. Kirkland, WA 98033 |
| Contact | Bert E Coates |
| Correspondent | Bert E Coates WRIGHT MEDICAL CORP. 11023 118TH PLACE N.E. Kirkland, WA 98033 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-05 |
| Decision Date | 1989-09-12 |