PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
FDA 510(k) clearance K041495 · decided 2005-04-15
Clearance details
- K-number
- K041495
- Device name
- PENTADEFLUE IV SOLUTION ADMINISTRATION SETS
- Applicant
- Pentaferte S.P.A
- Decision
- Substantially Equivalent
- Date received
- 2004-06-04
- Decision date
- 2005-04-15
- Days to decision
- 315 days
- Clearance type
- Abbreviated
- Product code
- FPA
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Campli (Teramo), IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.