510(k) K031419
K031419 is an FDA 510(k) premarket notification submitted by Laboratorios Grifols, S.A. for the device "GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML". The FDA issued a decision of Substantially Equivalent on Nov 24, 2003. The device falls under product code KPE (Container, I.V.), a Class II device regulated under 21 CFR 880.5025. Laboratorios Grifols, S.A. has 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 24, 2003
- Date Received
- May 5, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Container, I.V.
- Device Class
- Class II
- Regulation Number
- 880.5025
- Review Panel
- HO
- Submission Type
- 510(k)