510(k) K980587
K980587 is an FDA 510(k) premarket notification submitted by Inrad for the device "IV DECANTER-FLEXIBLE". The FDA issued a decision of Substantially Equivalent on April 17, 1998. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Inrad has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 1998
- Date Received
- February 17, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, I.V. Fluid Transfer
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type