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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 K851075
Device Name NORELCO DIGITAL MODEL 970 THERMOMETER
Applicant
Philips Park
P.O. Box 500
Essex,  CT  06426
Applicant Contact COVELEY
Correspondent
Philips Park
P.O. Box 500
Essex,  CT  06426
Correspondent Contact COVELEY
Regulation Number880.2910
Classification Product Code
FLL  
Date Received03/18/1985
Decision Date 04/04/1985
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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