PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
FDA 510(k) clearance K161897 · decided 2016-10-04
Clearance details
- K-number
- K161897
- Device name
- PREVENA DUO, PREVENA PLUS DUO Incision Management Systems with PEEL & PLACE Dressings
- Applicant
- Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2016-07-11
- Decision date
- 2016-10-04
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.