The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Enteral Only Extension Set.
| Device ID | K082654 |
| 510k Number | K082654 |
| Device Name: | ENTERAL ONLY EXTENSION SET |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Contact | Andrew P Zeltwanger |
| Correspondent | Andrew P Zeltwanger RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville, PA 15146 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-09-12 |
| Decision Date | 2008-11-25 |
| Summary: | summary |