The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Biopsy Valve.
| Device ID | K131426 |
| 510k Number | K131426 |
| Device Name: | MEDLINE BIOPSY VALVE |
| Classification | Endoscopic Irrigation/suction System |
| 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 | OCX |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-17 |
| Decision Date | 2014-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889942614196 | K131426 | 000 |