The following data is part of a premarket notification filed by Smash Ent., Inc. with the FDA for Entera* Enteral Feeding Bag.
| Device ID | K881162 |
| 510k Number | K881162 |
| Device Name: | ENTERA* ENTERAL FEEDING BAG |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | SMASH ENT., INC. 3585 LEXINGTON AVENUE NORTH SUITE 258 Arden Hills, MN 55126 |
| Contact | Janet L Zahn |
| Correspondent | Janet L Zahn SMASH ENT., INC. 3585 LEXINGTON AVENUE NORTH SUITE 258 Arden Hills, MN 55126 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-03-18 |
| Decision Date | 1988-06-03 |