PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
FDA 510(k) clearance K112127 · decided 2012-05-16
Clearance details
- K-number
- K112127
- Device name
- PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2011-07-25
- Decision date
- 2012-05-16
- Days to decision
- 296 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
- St Petersburg, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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