PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
FDA 510(k) clearance K123878 · decided 2013-01-15
Clearance details
- K-number
- K123878
- Device name
- PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING
- Applicant
- Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2012-12-17
- Decision date
- 2013-01-15
- Days to decision
- 29 days
- Clearance type
- Special
- 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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