T-SLING
FDA 510(k) clearance K050516 · decided 2006-02-03
Clearance details
- K-number
- K050516
- Device name
- T-SLING
- Applicant
- Herniamesh S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-01
- Decision date
- 2006-02-03
- Days to decision
- 339 days
- Clearance type
- Traditional
- Product code
- OTN
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Chivasso, Torino, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.