510(k) K040196
K040196 is an FDA 510(k) premarket notification submitted by Tyco Healthcare/Kendall for the device "KENDALL EPUMP ENTERAL FEEDING PUMP AND ENTERAL FEEDING SETS". The FDA issued a decision of Substantially Equivalent on May 5, 2004. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Tyco Healthcare/Kendall has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 5, 2004
- Date Received
- January 29, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Infusion, Enteral
- Device Class
- Class II
- Regulation Number
- 880.5725
- Review Panel
- HO
- Submission Type