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 | K934132 |
510k Number | K934132 |
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 | 1993-08-25 |
Decision Date | 1994-10-04 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
B462FLT1801Q5 | K934132 | 000 |
B462DBF23UPB5 | K934132 | 000 |
B462DBF23UHF5 | K934132 | 000 |
B462DBF23U5 | K934132 | 000 |
30884521617272 | K934132 | 000 |
10884521701328 | K934132 | 000 |
10884521670785 | K934132 | 000 |