510(k) K891575
K891575 is an FDA 510(k) premarket notification submitted by Sandoz Nutrition for the device "COMPAT ENTERAL FEED PUMP 199235 & 199240". The FDA issued a decision of Substantially Equivalent on Sep 12, 1989. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Sandoz Nutrition has 19 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 12, 1989
- Date Received
- Mar 20, 1989
- 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
- 510(k)