The following data is part of a premarket notification filed by Abbott Mfg., Inc. with the FDA for Flexiflo Quantum Enteral Pump.
| Device ID | K944669 |
| 510k Number | K944669 |
| Device Name: | FLEXIFLO QUANTUM ENTERAL PUMP |
| Classification | Pump, Infusion |
| 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 | FRN |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-13 |
| Decision Date | 1995-07-24 |