The following data is part of a premarket notification filed by Delmed, Inc. with the FDA for 600ml And 1200ml Enteral Bag Adm. Set For Entera.
| Device ID | K895329 |
| 510k Number | K895329 |
| Device Name: | 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | DELMED, INC. 120 ALBANY ST. P.O. BOX 2623 New Brunswick, NJ 08903 |
| Contact | Susan Revelj |
| Correspondent | Susan Revelj DELMED, 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 | 1989-08-31 |
| Decision Date | 1990-10-02 |