The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Ultrafree-cl.
| Device ID | K941326 |
| 510k Number | K941326 |
| Device Name: | ULTRAFREE-CL |
| Classification | Clinical Sample Concentrator |
| Applicant | MILLIPORE CORP. 80 ASHBY RD. Bedford, MA 01730 |
| Contact | Thomas G Borrows |
| Correspondent | Thomas G Borrows MILLIPORE CORP. 80 ASHBY RD. Bedford, MA 01730 |
| Product Code | JJH |
| CFR Regulation Number | 862.2310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-03-18 |
| Decision Date | 1994-05-27 |