The following data is part of a premarket notification filed by Hans J. Brouwers & Assoc. with the FDA for Plasma Extraction System.
| Device ID | K850391 |
| 510k Number | K850391 |
| Device Name: | PLASMA EXTRACTION SYSTEM |
| Classification | Device, Hematocrit Measuring |
| Applicant | HANS J. BROUWERS & ASSOC. P.O. BOX 823 Mount Prospect, IL 60056 |
| Contact | Hans J Brouwers |
| Correspondent | Hans J Brouwers HANS J. BROUWERS & ASSOC. P.O. BOX 823 Mount Prospect, IL 60056 |
| Product Code | JPI |
| CFR Regulation Number | 864.6400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-01 |
| Decision Date | 1985-05-10 |