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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K862333
Device Name (MT-27) THERMOMETER AND (M-10PC) PROBE COVERS
Applicant
Sharp Electronics Corp.
P.O.Box 650
Mahwah,  NJ  07430
Applicant Contact WEINBERG, PE
Correspondent
Sharp Electronics Corp.
P.O.Box 650
Mahwah,  NJ  07430
Correspondent Contact WEINBERG, PE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received06/19/1986
Decision Date 07/08/1986
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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