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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 K962991
Device Name BASIS BABY-TEMP PACIFIER DIGITAL THEROMETER
Applicant
Polymedica Industries, Inc.
581 Conference Pl.
Golden,  CO  80401
Applicant Contact JULIE CHAFFEE
Correspondent
Polymedica Industries, Inc.
581 Conference Pl.
Golden,  CO  80401
Correspondent Contact JULIE CHAFFEE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received08/01/1996
Decision Date 09/12/1996
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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