The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Anti-reflux Valve.
| Device ID | K132314 |
| 510k Number | K132314 |
| Device Name: | MEDLINE ANTI-REFLUX VALVE |
| Classification | Tube, Double Lumen For Intestinal Decompression And/or Intubation |
| 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 | FEG |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-25 |
| Decision Date | 2013-09-18 |