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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 K953465
Device Name KENTEMP
Applicant
Kentron Health Care, Inc.
4330 Sheridan St.
Hollywood,  FL  33021
Applicant Contact NARI SADARANGANI
Correspondent
Kentron Health Care, Inc.
4330 Sheridan St.
Hollywood,  FL  33021
Correspondent Contact NARI SADARANGANI
Regulation Number880.2920
Classification Product Code
FLK  
Date Received07/24/1995
Decision Date 12/15/1995
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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