The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Provox Activalve (size 4.5mm, 6mm, 8mm, 10mm, 12.5mm).
| Device ID | K092593 |
| 510k Number | K092593 |
| Device Name: | PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) |
| Classification | Prosthesis, Laryngeal (taub) |
| Applicant | ATOS MEDICAL AB KRAFTGATAN 8 Horby, SE Se-24222 |
| Contact | Ferenc Dahner |
| Correspondent | Ferenc Dahner ATOS MEDICAL AB KRAFTGATAN 8 Horby, SE Se-24222 |
| Product Code | EWL |
| CFR Regulation Number | 874.3730 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-24 |
| Decision Date | 2010-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07331791006944 | K092593 | 000 |
| 07331791000522 | K092593 | 000 |
| 07331791000539 | K092593 | 000 |
| 07331791000546 | K092593 | 000 |
| 07331791000553 | K092593 | 000 |
| 07331791000560 | K092593 | 000 |
| 07331791000577 | K092593 | 000 |
| 07331791000584 | K092593 | 000 |
| 07331791000591 | K092593 | 000 |
| 07331791000607 | K092593 | 000 |
| 07331791000614 | K092593 | 000 |
| 07331791000621 | K092593 | 000 |
| 07331791000638 | K092593 | 000 |
| 07331791000645 | K092593 | 000 |
| 07331791000652 | K092593 | 000 |
| 07331791000669 | K092593 | 000 |
| 07331791006920 | K092593 | 000 |
| 07331791006937 | K092593 | 000 |
| 07331791000515 | K092593 | 000 |