510(k) K791531
K791531 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "FLEXIFLO ENTERAL PUMP SET". The FDA issued a decision of Substantially Equivalent on September 12, 1979. The device falls under product code BSS (Tube, Nasogastric), a Class II device regulated under 21 CFR 876.5980. Abbott Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 12, 1979
- Date Received
- August 10, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Nasogastric
- Device Class
- Class II
- Regulation Number
- 876.5980
- Review Panel
- GU
- Submission Type