Product code FZM
- Device name
- Stool, Operating-Room
- Medical specialty
- General, Plastic Surgery
- Device class
- 1
- Regulation number
- 878.4950
- Review panel
- SU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K890309 | MALIS SURGICAL STOOL | Valley Forge Scientific Corp. | 1989-02-14 |
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| 04057027768129 | UFSK-OSYS Assistant's chair | UFSK-International OSYS GmbH | 2026-03-02 |
| 04057027777473 | UFSK-OSYS Assistant's chair | UFSK-International OSYS GmbH | 2026-03-02 |
| 04057027896099 | UFSK-OSYS Assistant's chair | UFSK-International OSYS GmbH | 2026-03-02 |
| 04057027924617 | UFSK-OSYS Assistant's chair | UFSK-International OSYS GmbH | 2026-03-02 |
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| 10810087352155 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10810087352148 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| 10810087352131 | Coulmed | Coulmed Products Group LLC | 2023-01-06 |
| M368GF1840C21 | LUMEX | GF HEALTH PRODUCTS, INC. | 2021-06-08 |
| M368GF184021 | LUMEX | GF HEALTH PRODUCTS, INC. | 2021-06-08 |