The following data is part of a premarket notification filed by Adept Medical Ltd with the FDA for Neozoline Ventilation Tubes.
| Device ID | K061058 |
| 510k Number | K061058 |
| Device Name: | NEOZOLINE VENTILATION TUBES |
| Classification | Tube, Tympanostomy |
| Applicant | ADEPT MEDICAL LTD P.O. BOX 10075 DOMINION ROAD Auckland, NZ |
| Contact | Jason Marsh |
| Correspondent | Jason Marsh ADEPT MEDICAL LTD P.O. BOX 10075 DOMINION ROAD Auckland, NZ |
| Product Code | ETD |
| CFR Regulation Number | 874.3880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421901970154 | K061058 | 000 |
| 09421901970017 | K061058 | 000 |
| 09421901970024 | K061058 | 000 |
| 09421901970031 | K061058 | 000 |
| 09421901970048 | K061058 | 000 |
| 09421901970062 | K061058 | 000 |
| 09421901970079 | K061058 | 000 |
| 09421901970086 | K061058 | 000 |
| 09421901970093 | K061058 | 000 |
| 09421901970109 | K061058 | 000 |
| 09421901970116 | K061058 | 000 |
| 09421901970123 | K061058 | 000 |
| 09421901970130 | K061058 | 000 |
| 09421901970147 | K061058 | 000 |
| 09421901970000 | K061058 | 000 |