Device Classification Name |
stimulator, caloric-water
|
510(k) Number |
K813552 |
Device Name |
MODEL 3000C CALORIC IRRIGATOR |
Applicant |
LIFE-TECH INTL., INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
LIFE-TECH INTL., INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 874.1800
|
Classification Product Code |
|
Date Received | 12/21/1981 |
Decision Date | 02/22/1982 |
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
|
|
|