The following data is part of a premarket notification filed by Millipore Corp. with the FDA for Millex Gp Sterilizing Filter Unit, Model Slgp 033 R.
| Device ID | K013988 |
| 510k Number | K013988 |
| Device Name: | MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R |
| Classification | Filter, Conduction, Anesthetic |
| Applicant | MILLIPORE CORP. 80 ASHBY RD. Bedford, MA 01730 |
| Contact | Thomas Borrows |
| Correspondent | Thomas Borrows MILLIPORE CORP. 80 ASHBY RD. Bedford, MA 01730 |
| Product Code | BSN |
| CFR Regulation Number | 868.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-04 |
| Decision Date | 2002-04-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04054839076602 | K013988 | 000 |
| 04054839076596 | K013988 | 000 |
| 04054839076510 | K013988 | 000 |
| 04054839076497 | K013988 | 000 |
| 04054839076251 | K013988 | 000 |