The following data is part of a premarket notification filed by Atlantean Corporation with the FDA for Atlantean Trigger Nebulizer.
| Device ID | K102719 |
| 510k Number | K102719 |
| Device Name: | ATLANTEAN TRIGGER NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | ATLANTEAN CORPORATION 29201 VIA NORTE Temecula, CA 92591 |
| Contact | Tom Shanks |
| Correspondent | Tom Shanks ATLANTEAN CORPORATION 29201 VIA NORTE Temecula, CA 92591 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-21 |
| Decision Date | 2011-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05055931102298 | K102719 | 000 |
| 05055931102090 | K102719 | 000 |
| 05055931102076 | K102719 | 000 |
| 05055931102052 | K102719 | 000 |
| 05055931102038 | K102719 | 000 |
| 05055931102014 | K102719 | 000 |
| 05055931101994 | K102719 | 000 |
| 05055931101970 | K102719 | 000 |
| 05055931101963 | K102719 | 000 |
| 05055931102113 | K102719 | 000 |
| 05055931102120 | K102719 | 000 |
| 05055931102274 | K102719 | 000 |
| 05055931102250 | K102719 | 000 |
| 05055931102236 | K102719 | 000 |
| 05055931102212 | K102719 | 000 |
| 05055931102199 | K102719 | 000 |
| 05055931102182 | K102719 | 000 |
| 05055931102168 | K102719 | 000 |
| 05055931102144 | K102719 | 000 |
| 05055931118824 | K102719 | 000 |