VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
FDA 510(k) clearance K162159 · decided 2017-04-28
Clearance details
- K-number
- K162159
- Device name
- VCare 1000-300S Pump, VCare 1000-300S System, Perme-foam Dressing
- Applicant
- Vr Medical Technologies, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-08-02
- Decision date
- 2017-04-28
- Days to decision
- 269 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
- Kunshan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.