NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
FDA 510(k) clearance K100163 · decided 2011-10-13
Clearance details
- K-number
- K100163
- Device name
- NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
- Applicant
- Vygon Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-01-20
- Decision date
- 2011-10-13
- Days to decision
- 631 days
- Clearance type
- Traditional
- Product code
- FPD
- Device class
- 2
- Regulation number
- 876.5980
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Montgomeryville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.