LIFESTITCH SUTURING DEVICE
FDA 510(k) clearance K013990 · decided 2002-02-27
Clearance details
- K-number
- K013990
- Device name
- LIFESTITCH SUTURING DEVICE
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2001-12-03
- Decision date
- 2002-02-27
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- GAT
- Device class
- 2
- Regulation number
- 878.5000
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.