AUTOSUTURE EEA ORVIL
FDA 510(k) clearance K093402 · decided 2009-11-12
Clearance details
- K-number
- K093402
- Device name
- AUTOSUTURE EEA ORVIL
- Applicant
- Surgical Devices, A Global Business Unit Tyco
- Decision
- Substantially Equivalent
- Date received
- 2009-11-02
- Decision date
- 2009-11-12
- Days to decision
- 10 days
- Clearance type
- Special
- Product code
- GDW
- Device class
- 2
- Regulation number
- 878.4750
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- North Haven, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.