Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K922187 |
Device Name |
COMPACT SPACER |
Applicant |
GLAXO, INC. |
5 MOORE DR. |
P.O. BOX 13358 |
RESEARCH TRIANGLE,
NC
27709
|
|
Applicant Contact |
THOMAS A GERDING |
Correspondent |
GLAXO, INC. |
5 MOORE DR. |
P.O. BOX 13358 |
RESEARCH TRIANGLE,
NC
27709
|
|
Correspondent Contact |
THOMAS A GERDING |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 05/11/1992 |
Decision Date | 11/20/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|