The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Millex, Dualex (plus, Ultra).
| Device ID | K934069 |
| 510k Number | K934069 |
| Device Name: | MILLEX, DUALEX (PLUS, ULTRA) |
| Classification | Protector, Transducer, Dialysis |
| Applicant | MILLIPORE CORP. 80 ASHBY RD. P.O. BOX 9125 Bedford, MA 01730 |
| Contact | Thomas G Borrows |
| Correspondent | Thomas G Borrows MILLIPORE CORP. 80 ASHBY RD. P.O. BOX 9125 Bedford, MA 01730 |
| Product Code | FIB |
| CFR Regulation Number | 876.5820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-20 |
| Decision Date | 1994-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04054839078217 | K934069 | 000 |
| 04053252397837 | K934069 | 000 |
| 04053252398018 | K934069 | 000 |
| 04053252660283 | K934069 | 000 |
| 04053252725180 | K934069 | 000 |
| 04054839076473 | K934069 | 000 |
| 04054839076565 | K934069 | 000 |
| 04054839076572 | K934069 | 000 |
| 04054839076756 | K934069 | 000 |
| 08436037123160 | K934069 | 000 |