The following data is part of a premarket notification filed by Sorensen Research with the FDA for Mediastinal Drainage Tube Set Mdt-36tc2.
| Device ID | K781553 |
| 510k Number | K781553 |
| Device Name: | MEDIASTINAL DRAINAGE TUBE SET MDT-36TC2 |
| Classification | Apparatus, Autotransfusion |
| Applicant | SORENSEN RESEARCH 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-12 |
| Decision Date | 1978-10-26 |