Device Classification Name |
Nebulizer (Direct Patient Interface)
|
510(k) Number |
K950867 |
Device Name |
MEDI - PUMP |
Applicant |
THOMAS INDUSTRIES |
1419 ILLINOIS AVE. |
P.O. BOX 29 |
SHEBOYGAN,
WI
53082 -0029
|
|
Applicant Contact |
DAN BREITZMAN |
Correspondent |
THOMAS INDUSTRIES |
1419 ILLINOIS AVE. |
P.O. BOX 29 |
SHEBOYGAN,
WI
53082 -0029
|
|
Correspondent Contact |
DAN BREITZMAN |
Regulation Number | 868.5630
|
Classification Product Code |
|
Date Received | 02/27/1995 |
Decision Date | 04/19/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|