The following data is part of a premarket notification filed by Medovations, Inc. with the FDA for Enteral Feeding Bag.
| Device ID | K854616 |
| 510k Number | K854616 |
| Device Name: | ENTERAL FEEDING BAG |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Contact | Sury R Shoney |
| Correspondent | Sury R Shoney MEDOVATIONS, INC. 102 EAST KEEFE AVE. Milwaukee, WI 53212 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-18 |
| Decision Date | 1986-01-23 |