The following data is part of a premarket notification filed by Pharma Systems Ab with the FDA for Bact-trap Hepa Midi.
| Device ID | K093426 |
| 510k Number | K093426 |
| Device Name: | BACT-TRAP HEPA MIDI |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | PHARMA SYSTEMS AB 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden PHARMA SYSTEMS AB 24301 WOODSAGE DR. Bonita Springs, FL 34134 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-11-03 |
| Decision Date | 2010-02-22 |
| Summary: | summary |