The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Gastrostomy Tube.
| Device ID | K073718 |
| 510k Number | K073718 |
| Device Name: | MEDLINE GASTROSTOMY TUBE |
| Classification | Tube, Gastro-enterostomy |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundelein, IL 60060 |
| Product Code | KGC |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-31 |
| Decision Date | 2008-03-19 |