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 |