The following data is part of a premarket notification filed by Atos Medical Ab with the FDA for Provox Vega Puncture Set.
| Device ID | K131947 |
| 510k Number | K131947 |
| Device Name: | PROVOX VEGA PUNCTURE SET |
| 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 (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-27 |
| Decision Date | 2013-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07331791009174 | K131947 | 000 |
| 07331791009099 | K131947 | 000 |
| 07331791009105 | K131947 | 000 |
| 07331791009112 | K131947 | 000 |
| 07331791009129 | K131947 | 000 |
| 07331791009136 | K131947 | 000 |
| 07331791009143 | K131947 | 000 |
| 07331791009150 | K131947 | 000 |
| 07331791009167 | K131947 | 000 |
| 07331791009082 | K131947 | 000 |