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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 K030961
Device Name MICROLIFE DIGITAL BASAL THERMOMETER, MODEL MT 1921
Applicant
MICROLIFE CORP.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
MICROLIFE CORP.
55 Northern Blvd.
Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Classification Product Code
LHD  
Date Received03/27/2003
Decision Date 09/12/2003
Decision Substantially Equivalent (SESE)
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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