The following data is part of a premarket notification filed by Novartis Nutrition Corp. with the FDA for Compat Mini-g Replacement Gastrostomy Tube.
| Device ID | K981323 |
| 510k Number | K981323 |
| Device Name: | COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | NOVARTIS NUTRITION CORP. 5320 WEST 23RD ST. PO BOX 370 Minneapolis, MN 55440 |
| Contact | Robert J Lang |
| Correspondent | Robert J Lang NOVARTIS NUTRITION CORP. 5320 WEST 23RD ST. PO BOX 370 Minneapolis, MN 55440 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-13 |
| Decision Date | 1998-10-09 |
| Summary: | summary |