Apparatus, Air Handling, Enclosure
FDA product code FZI · Class II (moderate risk) · 21 CFR 878.5070 · General, Plastic Surgery
5510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K911132 | Multiple, Surgical Drape PackFZI · Traditional | Central Georgia Ancillary Health Systems | 05/06/1991SE |
| K910468 | Sterile Disposable Drape(S)FZI · Traditional | E.M. Adams | 03/21/1991SE |
| K854159 | Ellipti-PunchFZI · Traditional | Alcon Laboratories | 11/15/1985SE |
| K772395 | Davis RhytidectomyFZI · Traditional | Edward Weck, Inc. | 03/09/1978SE |
| K772394 | Kalrn Face-Life ScissorsFZI · Traditional | Edward Weck, Inc. | 03/09/1978SE |