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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Strip, Temperature, Forehead, Liquid Crystal
510(k) Number K841913
Device Name TEMPTREND PEDS AXILLARY TEMP. INDICATOR
Applicant
Biosynergy, Inc.
724
West Algonquin Rd.
Arlington Heights,  IL  60005
Applicant Contact SHARON B MUIR
Correspondent
Biosynergy, Inc.
724
West Algonquin Rd.
Arlington Heights,  IL  60005
Correspondent Contact SHARON B MUIR
Regulation Number880.2200
Classification Product Code
KPD  
Date Received05/09/1984
Decision Date 11/02/1984
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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