510(k) K943733
K943733 is an FDA 510(k) premarket notification submitted by Abbott Mfg., Inc. for the device "FLEXIFLO SIX ENTERAL NUTRITION PUMP". The FDA issued a decision of ST on December 12, 1994. The device falls under product code LZH (Pump, Infusion, Enteral), a Class II device regulated under 21 CFR 880.5725. Abbott Mfg., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- ST ()
- Decision Date
- December 12, 1994
- Date Received
- August 2, 1994
- 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