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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 K935466
Device Name CLINICAL VOICE THERMOMETER
Applicant
Blazie Engineering, Inc.
105 E. Jarrettsville Rd.
Forest Hill,  MD  21050
Applicant Contact DEANE BLAZIE
Correspondent
Blazie Engineering, Inc.
105 E. Jarrettsville Rd.
Forest Hill,  MD  21050
Correspondent Contact DEANE BLAZIE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/12/1993
Decision Date 04/13/1995
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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