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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 K900646
Device Name MERCURY THERMOMETERS (ORAL AND RECTAL)
Applicant
Abel Industries, Inc.
109 Highland Ave.
Needham,  MA  02194
Applicant Contact MARVIN MALTZ
Correspondent
Abel Industries, Inc.
109 Highland Ave.
Needham,  MA  02194
Correspondent Contact MARVIN MALTZ
Regulation Number880.2920
Classification Product Code
FLK  
Date Received02/09/1990
Decision Date 07/11/1990
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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