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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 K971994
Device Name B-D ASSURE EAR THERMOMETER
Applicant
Becton Dickinson Consumer Products
One Becton Dr.
Franklin Lake,  NJ  07417
Applicant Contact PETER ZURLO
Correspondent
Becton Dickinson Consumer Products
One Becton Dr.
Franklin Lake,  NJ  07417
Correspondent Contact PETER ZURLO
Regulation Number880.2910
Classification Product Code
FLL  
Date Received05/29/1997
Decision Date 05/01/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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