The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Flexiflo Six Enteral Nutrition Pump.
Device ID | K943733 |
510k Number | K943733 |
Device Name: | FLEXIFLO SIX ENTERAL NUTRITION PUMP |
Classification | Pump, Infusion, Enteral |
Applicant | ABBOTT MFG., INC. 1033 KINGSMILL PKWY. Columbus, OH 43229 |
Contact | Michael H Haney |
Correspondent | Michael H Haney ABBOTT MFG., INC. 1033 KINGSMILL PKWY. Columbus, OH 43229 |
Product Code | LZH |
CFR Regulation Number | 880.5725 [🔎] |
Decision | Se Subject To Tracking Reg (ST) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-02 |
Decision Date | 1994-12-12 |