Venturi Gauze Wound Care Sets with Portal Drain
FDA 510(k) clearance K151263 · decided 2016-02-19
Clearance details
- K-number
- K151263
- Device name
- Venturi Gauze Wound Care Sets with Portal Drain
- Applicant
- Talley Group, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2015-05-13
- Decision date
- 2016-02-19
- Days to decision
- 282 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
- Romsey, GB
- 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.