The following data is part of a premarket notification filed by Moss Tubes, Inc. with the FDA for Moss Gastrostomy Tube.
| Device ID | K990389 |
| 510k Number | K990389 |
| Device Name: | MOSS GASTROSTOMY TUBE |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MOSS TUBES, INC. 304 VERONA AVE. Elizabeth, NJ 07208 |
| Contact | Harry Schlakman |
| Correspondent | Harry 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 | 1999-02-08 |
| Decision Date | 1999-03-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00866459000400 | K990389 | 000 |