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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 K931747
Device Name FEVER MONITORING KIT
Applicant
Polymedica Healthcare, Inc.
581 Conference Pl.
Golden,,  CO  80401
Applicant Contact ROBERT J ZAPPA
Correspondent
Polymedica Healthcare, Inc.
581 Conference Pl.
Golden,,  CO  80401
Correspondent Contact ROBERT J ZAPPA
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/08/1993
Decision Date 12/13/1993
Decision Substantially Equivalent - Kit (SESK)
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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