Device Classification Name |
Stimulator, Caloric-Air
|
510(k) Number |
K941325 |
Device Name |
WATER IRRIGATOR, W1 200 |
Applicant |
STRONG MEDICAL, INC. |
STREET X, INDUSTRIAL AREA |
HERAKLION,
GR
|
|
Applicant Contact |
PAUL MCAFEE |
Correspondent |
STRONG MEDICAL, INC. |
STREET X, INDUSTRIAL AREA |
HERAKLION,
GR
|
|
Correspondent Contact |
PAUL MCAFEE |
Regulation Number | 874.1800
|
Classification Product Code |
|
Date Received | 03/18/1994 |
Decision Date | 08/09/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|