The following data is part of a premarket notification filed by Aerogen Ltd with the FDA for Continuous Nebulization Tube Set (cnts) Tubing: Ag-as3075 + Syringe: Ag-as3085; Continous Nebulization Tube Set (cnts) S.
| Device ID | K103635 |
| 510k Number | K103635 |
| Device Name: | CONTINUOUS NEBULIZATION TUBE SET (CNTS) TUBING: AG-AS3075 + SYRINGE: AG-AS3085; CONTINOUS NEBULIZATION TUBE SET (CNTS) S |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | AEROGEN LTD GALWAY BUSINESS PARK, DANGAN Galway, IE Galway |
| Contact | Martha Folan |
| Correspondent | Martha Folan AEROGEN LTD GALWAY BUSINESS PARK, DANGAN Galway, IE Galway |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-13 |
| Decision Date | 2011-05-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391517933284 | K103635 | 000 |
| 05391517933260 | K103635 | 000 |
| 05391517931181 | K103635 | 000 |
| 05391517930412 | K103635 | 000 |
| 05391517930405 | K103635 | 000 |
| 05391517936216 | K103635 | 000 |
| 05391517936209 | K103635 | 000 |