FLEBOSET MULTIPLE
FDA 510(k) clearance K040456 · decided 2004-03-09
Clearance details
- K-number
- K040456
- Device name
- FLEBOSET MULTIPLE
- Applicant
- Laboratorios Grifols, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-23
- Decision date
- 2004-03-09
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- LHI
- Device class
- 2
- Regulation number
- 880.5440
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Parets Del Valles, Barcelona, ES
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.