510(k) K896907
K896907 is an FDA 510(k) premarket notification submitted by 3M Company for the device "3M IV FLOW REGULATOR". The FDA issued a decision of Substantially Equivalent on February 26, 1990. The device falls under product code LDR (Controller, Infusion, Intravascular, Electronic), a Class II device regulated under 21 CFR 880.5725. 3M Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 26, 1990
- Date Received
- December 8, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Controller, Infusion, Intravascular, Electronic
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type