The following data is part of a premarket notification filed by Medline, Industries, Inc. with the FDA for Medline High Pressure Injection Tubing.
| Device ID | K120008 |
| 510k Number | K120008 |
| Device Name: | MEDLINE HIGH PRESSURE INJECTION TUBING |
| Classification | Catheter, Intravascular, Diagnostic |
| 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 | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-03 |
| Decision Date | 2012-08-17 |