510(k) K791531

FLEXIFLO ENTERAL PUMP SET by Abbott Laboratories — Product Code BSS

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