The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Stopcock And Manifold.
| Device ID | K120069 |
| 510k Number | K120069 |
| Device Name: | MEDLINE STOPCOCK AND MANIFOLD |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| 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 | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-09 |
| Decision Date | 2012-04-03 |