The following data is part of a premarket notification filed by Thayer Medical Corp. with the FDA for Hand Held Medispacer.
| Device ID | K972237 |
| 510k Number | K972237 |
| Device Name: | HAND HELD MEDISPACER |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | THAYER MEDICAL CORP. 4575 SOUTH PALO VERDE RD., SUITE 337 Tucson, AZ 85714 |
| Contact | Joe Lix |
| Correspondent | Joe Lix THAYER MEDICAL CORP. 4575 SOUTH PALO VERDE RD., SUITE 337 Tucson, AZ 85714 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-01 |
| Decision Date | 1997-07-31 |