The following data is part of a premarket notification filed by Thayer Medical Corporation with the FDA for Minispacer(r) Mdi Adapter With Counter Incrementing Actuator.
| Device ID | K111570 |
| 510k Number | K111570 |
| Device Name: | MINISPACER(R) MDI ADAPTER WITH COUNTER INCREMENTING ACTUATOR |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | THAYER MEDICAL CORPORATION 4575 SOUTH PALO VERDE Road SUITE 337 Tucson, AZ 85714 -1961 |
| Contact | Erika S Strickland |
| Correspondent | Erika S Strickland THAYER MEDICAL CORPORATION 4575 SOUTH PALO VERDE Road SUITE 337 Tucson, AZ 85714 -1961 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-06 |
| Decision Date | 2011-09-29 |