DEVILBISS SUCTION UNIT
FDA 510(k) clearance K982304 · decided 1998-09-25
Clearance details
- K-number
- K982304
- Device name
- DEVILBISS SUCTION UNIT
- Applicant
- Sunrise Medical Hhg, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-07-01
- Decision date
- 1998-09-25
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- JCX
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Somerset, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DeVilbiss Model 7305P-D Powered Suction Unit recall (Z-2246-2016) | DeVilbiss Healthcare LLC | 2016-07-20 |
| DeVilbiss Vacu-Aide QSU Suction Unit (Disposable Suction Container/Filter), 800 ML DISP Co recall (Z-2319-2013) | DeVilbiss Healthcare LLC | 2013-10-01 |
| DeVilbiss Model 7310PR-D VacuAide Compact Suction Unit. A portable, AC-powered or compress recall (Z-0863-2009) | Sunrise Medical | 2009-02-10 |