The following data is part of a premarket notification filed by Moss Tubes, Inc. with the FDA for Moss Tubes, Inc, All Silicone Gastrostomy Tube.
| Device ID | K984310 |
| 510k Number | K984310 |
| Device Name: | MOSS TUBES, INC, ALL SILICONE GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MOSS TUBES, INC. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Contact | Harry A Schlakman |
| Correspondent | Harry A Schlakman MOSS TUBES, INC. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-12-02 |
| Decision Date | 1999-02-24 |