The following data is part of a premarket notification filed by Thayer Medical Corp. with the FDA for Dual Spray Minispacer.
Device ID | K955805 |
510k Number | K955805 |
Device Name: | DUAL SPRAY MINISPACER |
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 | 1995-12-22 |
Decision Date | 1996-03-21 |