UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT
FDA 510(k) clearance K133333 · decided 2014-12-31
Clearance details
- K-number
- K133333
- Device name
- UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT
- Applicant
- Blue Ocean Medical Product, LLC
- Decision
- Substantially Equivalent
- Date received
- 2013-10-29
- Decision date
- 2014-12-31
- Days to decision
- 428 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
- Crofton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.