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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Fertility Diagnostic, Proceptive
510(k) Number K945427
Device Name B-D DIGITAL THERMOMETER
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Applicant Contact PETER ZURLO
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
One Becton Dr.
Franklin Lake,  NJ  07417
Correspondent Contact PETER ZURLO
Classification Product Code
LHD  
Date Received11/04/1994
Decision Date 06/15/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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