The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Dual Port Enteral Y-adaptor.
| Device ID | K923168 |
| 510k Number | K923168 |
| Device Name: | DUAL PORT ENTERAL Y-ADAPTOR |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Contact | John Laemmar |
| Correspondent | John Laemmar ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-06-29 |
| Decision Date | 1994-06-17 |