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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 K852801
Device Name BIOCHRON FERTILITY INDICATOR
Applicant
Fertil-A-Chron, Inc.
350 Motor Pkwy.
Hauppauge,  NY  11788
Applicant Contact RUSSELL J VARANO
Correspondent
Fertil-A-Chron, Inc.
350 Motor Pkwy.
Hauppauge,  NY  11788
Correspondent Contact RUSSELL J VARANO
Classification Product Code
LHD  
Date Received07/01/1985
Decision Date 09/19/1985
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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