FXW — Shoes, Operating-Room Class I
FDA product code FXW covers "Shoes, Operating-Room", a Class I medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- FXW
- Device Class
- Class I
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- SU
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K923187 | dynatech medical products | IMPERVIOUS ISOLATION SHOE COVERS | January 29, 1993 |