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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 K904955
Device Name CONSUMER SENSORY PRODUCTS BIO-LOG 8000
Applicant
Consumer Sensory Products, Inc.
378 Cambridge Ave.
Suite G
Palo Alto,  CA  94306
Applicant Contact BAKUL HEREKAR
Correspondent
Consumer Sensory Products, Inc.
378 Cambridge Ave.
Suite G
Palo Alto,  CA  94306
Correspondent Contact BAKUL HEREKAR
Regulation Number880.2910
Classification Product Code
FLL  
Date Received11/05/1990
Decision Date 04/25/1991
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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