The following data is part of a premarket notification filed by Porous Media Corp. with the FDA for Porous Media Dbf23 Disposable Respiratory Filter.
Device ID | K964979 |
510k Number | K964979 |
Device Name: | POROUS MEDIA DBF23 DISPOSABLE 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 | 1996-12-12 |
Decision Date | 1997-03-11 |