FZM · Stool, Operating-Room
General, Plastic Surgery · 21 CFR 878.4950 · Class 1
Overview
| Product Code | FZM |
|---|---|
| Device Name | Stool, Operating-Room |
| Regulation | 21 CFR 878.4950 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K890309 | MALIS SURGICAL STOOL | Valley Forge Scientific Corp. | Feb 14, 1989 | SESE |
Top Applicants
- Valley Forge Scientific Corp. — 1 clearance
