TENOLIG
FDA 510(k) clearance K060367 · decided 2006-08-09
Clearance details
- K-number
- K060367
- Device name
- TENOLIG
- Applicant
- Fournitures Hospitalieres Industrie
- Decision
- Substantially Equivalent
- Date received
- 2006-02-13
- Decision date
- 2006-08-09
- Days to decision
- 177 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
- Quimper Finistere, FR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.