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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 K951939
Device Name TENDER TEMP
Applicant
Investech, Ltd.
3499 Woodley Park Pl.
Oviedo,  FL  32765
Applicant Contact ROBERT T HANDREN, JR.
Correspondent
Investech, Ltd.
3499 Woodley Park Pl.
Oviedo,  FL  32765
Correspondent Contact ROBERT T HANDREN, JR.
Regulation Number880.2910
Classification Product Code
FLL  
Date Received04/25/1995
Decision Date 09/01/1995
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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