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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Thermometer, Clinical Color Change
510(k) Number K894893
Device Name POINT CHECKER COLOR STRIP THERMOMETER
Applicant
Kyowa Medex Co., Ltd.
1401 Wilson Blvd.
Suite 400
Arlington,  VA  22209
Applicant Contact LYNNE N SEEKAMP
Correspondent
Kyowa Medex Co., Ltd.
1401 Wilson Blvd.
Suite 400
Arlington,  VA  22209
Correspondent Contact LYNNE N SEEKAMP
Regulation Number880.2900
Classification Product Code
FQZ  
Date Received08/01/1989
Decision Date 04/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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