MULTITAK SUTURE SNAP SYSTEM
FDA 510(k) clearance K013177 · decided 2001-12-19
Clearance details
- K-number
- K013177
- Device name
- MULTITAK SUTURE SNAP SYSTEM
- Applicant
- Bonutti Research, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-24
- Decision date
- 2001-12-19
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- GAM
- Device class
- 2
- Regulation number
- 878.4493
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Effingham, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.