The following data is part of a premarket notification filed by Orion Life Systems, Inc. with the FDA for Orion Life Systems Replacement Gastrostomy Tube.
| Device ID | K904801 |
| 510k Number | K904801 |
| Device Name: | ORION LIFE SYSTEMS REPLACEMENT GASTROSTOMY TUBE |
| Classification | Tube, Gastro-enterostomy |
| Applicant | ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Contact | John L Laemmar |
| Correspondent | John L Laemmar ORION LIFE SYSTEMS, INC. 124 MESSNER DR. Wheeling, IL 60090 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-24 |
| Decision Date | 1991-01-16 |