V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
FDA 510(k) clearance K160451 · decided 2016-06-20
Clearance details
- K-number
- K160451
- Device name
- V. A.C. VeraFlo Cleanse Choice Dressing System for use with the V.A.C. Ulta ...
- Applicant
- Kci USA, Inc. (Kinetic Concepts, Inc.)
- Decision
- Substantially Equivalent
- Date received
- 2016-02-18
- Decision date
- 2016-06-20
- Days to decision
- 123 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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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.