The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Flexiflo Enteral Pump Set.
Device ID | K791531 |
510k Number | K791531 |
Device Name: | FLEXIFLO ENTERAL PUMP SET |
Classification | Tube, Nasogastric |
Applicant | ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park, IL 60064 -3500 |
Product Code | BSS |
CFR Regulation Number | 876.5980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-08-10 |
Decision Date | 1979-09-12 |