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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 Mercury
510(k) Number K960185
Device Name AMSINO CLINICAL THERMOMETER
Applicant
Amsia Intl., Inc.
833 Towne Center Dr.
Pomona,  CA  91767
Applicant Contact RICHARD Y LI, PH.D.
Correspondent
Amsia Intl., Inc.
833 Towne Center Dr.
Pomona,  CA  91767
Correspondent Contact RICHARD Y LI, PH.D.
Regulation Number880.2920
Classification Product Code
FLK  
Date Received01/16/1996
Decision Date 03/28/1996
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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