Device Classification Name |
Accessory, Assisted Reproduction
|
510(k) Number |
K991263 |
Device Name |
THERMOPLATE |
Applicant |
TOKAI HIT CO., LTD. |
306-1 GENDOJI-CHO |
FUJINOMIYA-SHI, SHIZUOKA-KEN,
JP
418-0074
|
|
Applicant Contact |
HIDEHARU TSUCHIYA |
Correspondent |
TOKAI HIT CO., LTD. |
306-1 GENDOJI-CHO |
FUJINOMIYA-SHI, SHIZUOKA-KEN,
JP
418-0074
|
|
Correspondent Contact |
HIDEHARU TSUCHIYA |
Regulation Number | 884.6120
|
Classification Product Code |
|
Date Received | 04/13/1999 |
Decision Date | 07/08/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Obstetrics/Gynecology
|
510k Review Panel |
Obstetrics/Gynecology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|