The following data is part of a premarket notification filed by Flexicare Medical Limited with the FDA for Hepashield Bacterial Viral Breathing System Filter.
| Device ID | K191909 |
| 510k Number | K191909 |
| Device Name: | HepaShield Bacterial Viral Breathing System Filter |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, GB Cf45 4er |
| Contact | Joel Biddle |
| Correspondent | Joel Biddle Flexicare Medical Limited Cynon Valley Business Park Mountain Ash, GB Cf45 4er |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-17 |
| Decision Date | 2020-03-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055931102342 | K191909 | 000 |
| 05055931102335 | K191909 | 000 |
| 05055788777175 | K191909 | 000 |
| 05055788772293 | K191909 | 000 |
| 05055788772286 | K191909 | 000 |