The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Millex - Mp Filter Unit (slmpo25ss/slmpl25ss).
| Device ID | K963717 |
| 510k Number | K963717 |
| Device Name: | MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS) |
| Classification | Filter, Conduction, Anesthetic |
| 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 | BSN |
| CFR Regulation Number | 868.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-09-16 |
| Decision Date | 1997-06-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04054839076749 | K963717 | 000 |
| 04054839076732 | K963717 | 000 |