The following data is part of a premarket notification filed by Fresenius Usa, Inc. with the FDA for Enteral Pump Set With Entera (tm)-flo Spike.
| Device ID | K895366 |
| 510k Number | K895366 |
| Device Name: | ENTERAL PUMP SET WITH ENTERA (TM)-FLO SPIKE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | FRESENIUS USA, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Contact | Michele Dziedzic |
| Correspondent | Michele Dziedzic FRESENIUS USA, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-28 |
| Decision Date | 1990-05-02 |