INTEGRA SL
FDA 510(k) clearance K062147 · decided 2006-10-20
Clearance details
- K-number
- K062147
- Device name
- INTEGRA SL
- Applicant
- Direx Systems Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-27
- Decision date
- 2006-10-20
- Days to decision
- 85 days
- Clearance type
- Special
- Product code
- LNS
- Device class
- 2
- Regulation number
- 876.5990
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Canton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.