The following data is part of a premarket notification filed by Armstrong Medical Ltd. with the FDA for Spirale Drug Delivery System.
| Device ID | K111246 |
| 510k Number | K111246 |
| Device Name: | SPIRALE DRUG DELIVERY SYSTEM |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | ARMSTRONG MEDICAL LTD. WATTSTOWN BUSINESS PARK NEWBRIDGE RD. Coleraine, IE Bt52 1bs |
| Contact | Ian Stewart |
| Correspondent | Ian Stewart ARMSTRONG MEDICAL LTD. WATTSTOWN BUSINESS PARK NEWBRIDGE RD. Coleraine, IE Bt52 1bs |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-05-04 |
| Decision Date | 2012-08-10 |
| Summary: | summary |