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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 K952756
Device Name MEDI-AID BASAL THERMOMETER
Applicant
Polymedica Industries, Inc.
581 Conference Place
Golden,,  CO  80401
Applicant Contact JULIE CHAFFEE
Correspondent
Polymedica Industries, Inc.
581 Conference Place
Golden,,  CO  80401
Correspondent Contact JULIE CHAFFEE
Classification Product Code
LHD  
Date Received06/16/1995
Decision Date 09/25/1995
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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