The following data is part of a premarket notification filed by Thayer Medical Corp. with the FDA for Minispacer Dual-spray Mdi Adapter With 22mm (or 15mm) Od / 22mm Od/id Connections / 15mm Id Connections.
| Device ID | K102658 |
| 510k Number | K102658 |
| Device Name: | MINISPACER DUAL-SPRAY MDI ADAPTER WITH 22MM (OR 15MM) OD / 22MM OD/ID CONNECTIONS / 15MM ID CONNECTIONS |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | THAYER MEDICAL CORP. 4575 SOUTH PALO VERDE RD., SUITE 337 Tucson, AZ 85714 -1961 |
| Contact | James M Strickland |
| Correspondent | James M Strickland THAYER MEDICAL CORP. 4575 SOUTH PALO VERDE RD., SUITE 337 Tucson, AZ 85714 -1961 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-15 |
| Decision Date | 2010-12-10 |
| Summary: | summary |