The following data is part of a premarket notification filed by Flexicare Medical Ltd. with the FDA for Flexicare Breathing Filters.
| Device ID | K092218 |
| 510k Number | K092218 |
| Device Name: | FLEXICARE BREATHING FILTERS |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | FLEXICARE MEDICAL LTD. CYNON VALLEY BUSINESS PARK MOUNTAIN ASH Mid Glamorgan, GB Cf45 4er |
| Contact | David Moynham |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-07-22 |
| Decision Date | 2009-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055788777168 | K092218 | 000 |
| 05055788714637 | K092218 | 000 |
| 05055788740629 | K092218 | 000 |
| 05055788740759 | K092218 | 000 |
| 05055788741589 | K092218 | 000 |
| 05055788741732 | K092218 | 000 |
| 05055788742579 | K092218 | 000 |
| 05055788770190 | K092218 | 000 |
| 05055788770206 | K092218 | 000 |
| 05055788772255 | K092218 | 000 |
| 05055788772262 | K092218 | 000 |
| 05055788772279 | K092218 | 000 |
| 05055788773481 | K092218 | 000 |
| 05055788773498 | K092218 | 000 |
| 05055788773528 | K092218 | 000 |
| 05055788705390 | K092218 | 000 |