SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE
FDA 510(k) clearance K033682 · decided 2003-12-17
Clearance details
- K-number
- K033682
- Device name
- SET GRI-FILL 2.0-1 WAY; 2.0-2 WAYS; LUER CONNECTION TUBE
- Applicant
- Laboratorios Grifols, S.A.
- Decision
- Substantially Equivalent
- Date received
- 2003-11-24
- Decision date
- 2003-12-17
- Days to decision
- 23 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.