The following data is part of a premarket notification filed by Entech, Inc. with the FDA for Top-port Enteral Feeding Bag And Preattached Sets.
| Device ID | K861552 |
| 510k Number | K861552 |
| Device Name: | TOP-PORT ENTERAL FEEDING BAG AND PREATTACHED SETS |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ENTECH, INC. ROUTE 22 EAST Lebanon, NJ 08833 |
| Contact | Laurence A Potter |
| Correspondent | Laurence A Potter ENTECH, INC. ROUTE 22 EAST Lebanon, NJ 08833 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-25 |
| Decision Date | 1986-06-16 |