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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 Color Change
510(k) Number K946046
Device Name DEROYAL TECHNOLOGICES, INC. LIQUID CRYSTAL SKIN TEMPERATURE STRIP
Applicant
Deroyal Critical Care, Div. Deroyal Technologies
200 Debusk Ln.
Powell,  TN  37849
Applicant Contact DEBRA F MANNING
Correspondent
Deroyal Critical Care, Div. Deroyal Technologies
200 Debusk Ln.
Powell,  TN  37849
Correspondent Contact DEBRA F MANNING
Regulation Number880.2900
Classification Product Code
FQZ  
Date Received12/12/1994
Decision Date 07/19/1995
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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