TRIFLEX SELECT
FDA 510(k) clearance K070647 · decided 2007-06-22
Clearance details
- K-number
- K070647
- Device name
- TRIFLEX SELECT
- Applicant
- Cardinal Health, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-03-08
- Decision date
- 2007-06-22
- Days to decision
- 106 days
- Clearance type
- Special
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Waukegan, IL, US
- 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.