EVA TPN BAG
FDA 510(k) clearance K101412 · decided 2011-04-13
Clearance details
- K-number
- K101412
- Device name
- EVA TPN BAG
- Applicant
- Valmed S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-20
- Decision date
- 2011-04-13
- Days to decision
- 328 days
- Clearance type
- Traditional
- Product code
- KPE
- Device class
- 2
- Regulation number
- 880.5025
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mazzo Di Valtellina So, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.