The following data is part of a premarket notification filed by Moss Tubes, Inc. with the FDA for Moss Gastrostomy Tube, Moss Nasal Tube – Mark Iv.
| Device ID | K190414 |
| 510k Number | K190414 |
| Device Name: | Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | Moss Tubes, Inc. 1929 Route 9 Castleton On Hudson, NY 12033 |
| Contact | Michael Moss |
| Correspondent | Meghan Mcgovern Xeridiem Medical Devices 4700 South Overland Drive Tucson, AZ 85714 |
| Product Code | PIF |
| Subsequent Product Code | BSS |
| Subsequent Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-21 |
| Decision Date | 2019-06-14 |