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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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 Number884.6120
Classification Product Code
MQG  
Date Received04/13/1999
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
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