Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K955805 |
Device Name |
DUAL SPRAY MINISPACER |
Applicant |
THAYER MEDICAL CORP. |
4575 SOUTH PALO VERDE RD., |
SUITE 337 |
TUCSON,
AZ
85714
|
|
Applicant Contact |
JOE LIX |
Correspondent |
THAYER MEDICAL CORP. |
4575 SOUTH PALO VERDE RD., |
SUITE 337 |
TUCSON,
AZ
85714
|
|
Correspondent Contact |
JOE LIX |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 12/22/1995 |
Decision Date | 03/21/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|