510(k) K090459
K090459 is an FDA 510(k) premarket notification submitted by Shan Dong Wei Gao Group Medical Polymer Products for the device "DISPOSABLE TPE INFUSION SET". The FDA issued a decision of Substantially Equivalent on October 13, 2009. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Shan Dong Wei Gao Group Medical Polymer Products has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 2009
- Date Received
- February 23, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Administration, Intravascular
- Device Class
- Class II
- Regulation Number
- 880.5440
- Review Panel
- HO
- Submission Type