The following data is part of a premarket notification filed by Sorensen Research with the FDA for Volume Control Device Vcd-150.
| Device ID | K780465 |
| 510k Number | K780465 |
| Device Name: | VOLUME CONTROL DEVICE VCD-150 |
| Classification | Infusor, Pressure, For I.v. Bags |
| Applicant | SORENSEN RESEARCH 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KZD |
| CFR Regulation Number | 880.5420 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-03-22 |
| Decision Date | 1978-06-02 |