The following data is part of a premarket notification filed by White River (tm) with the FDA for Entroset-sw.
| Device ID | K871003 |
| 510k Number | K871003 |
| Device Name: | ENTROSET-SW |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | WHITE RIVER (TM) P.O. BOX 1704 Beaverton, OR 97005 |
| Contact | Elena Grant |
| Correspondent | Elena Grant WHITE RIVER (TM) P.O. BOX 1704 Beaverton, OR 97005 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-03-12 |
| Decision Date | 1987-06-04 |