Device Classification Name |
Stimulator, Caloric-Air
|
510(k) Number |
K881630 |
Device Name |
AUTOMATIC CALORIC IRRIGATION SYSTEM |
Applicant |
ICS MEDICAL CORP. |
2227 HAMMOND DR. |
SCHAUMBURG,
IL
60173 -3860
|
|
Applicant Contact |
DELMAR F BLOEM |
Correspondent |
ICS MEDICAL CORP. |
2227 HAMMOND DR. |
SCHAUMBURG,
IL
60173 -3860
|
|
Correspondent Contact |
DELMAR F BLOEM |
Regulation Number | 874.1800
|
Classification Product Code |
|
Date Received | 04/14/1988 |
Decision Date | 06/21/1988 |
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
|
|
|