extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
FDA 510(k) clearance K143362 · decided 2015-02-03
Clearance details
- K-number
- K143362
- Device name
- extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister
- Applicant
- Devon Medical Products
- Decision
- Substantially Equivalent
- Date received
- 2014-11-24
- Decision date
- 2015-02-03
- Days to decision
- 71 days
- Clearance type
- Special
- Product code
- OMP
- Device class
- 2
- Regulation number
- 878.4780
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- King Of Prussia, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.