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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 K904211
Device Name BIOSELF 2000 FERTILITY INDICATOR
Applicant
Bioself, Inc.
7, Ave. De Thonex
Case Postale 172-Ch-1226
Thonex-Geneve-Suisse,  CH
Applicant Contact JAMES PULCRANO
Correspondent
Bioself, Inc.
7, Ave. De Thonex
Case Postale 172-Ch-1226
Thonex-Geneve-Suisse,  CH
Correspondent Contact JAMES PULCRANO
Classification Product Code
LHD  
Date Received09/12/1990
Decision Date 10/14/1992
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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