The following data is part of a premarket notification filed by Porous Media Corp. with the FDA for Porous Media Dbf23 Reusable Respiratory Filter.
| Device ID | K965020 |
| 510k Number | K965020 |
| Device Name: | POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | POROUS MEDIA CORP. 1350 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Keith A Roberts |
| Correspondent | Keith A Roberts POROUS MEDIA CORP. 1350 HAMMOND RD. St. Paul, MN 55110 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-16 |
| Decision Date | 1997-03-14 |