FORYOU NPWT DEVICE
FDA 510(k) clearance K113236 · decided 2013-02-12
Clearance details
- K-number
- K113236
- Device name
- FORYOU NPWT DEVICE
- Applicant
- Foryou Medical Electronics Co, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-02
- Decision date
- 2013-02-12
- Days to decision
- 468 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
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.