The following data is part of a premarket notification filed by Exceleron Medical with the FDA for Exceleron Bacterial Filters.
| Device ID | K131626 |
| 510k Number | K131626 |
| Device Name: | EXCELERON BACTERIAL FILTERS |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | EXCELERON MEDICAL 4486 TIMBERLINE CT Vadnais Heights, MN 55127 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath EXCELERON MEDICAL 4486 TIMBERLINE CT Vadnais Heights, MN 55127 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-04 |
| Decision Date | 2014-02-26 |
| Summary: | summary |