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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 K843699
Device Name BIOSELF TM 110
Applicant
Bioself, Inc.
C.P. 70
Saint-Lambert, Que. Canad, 
Applicant Contact YVES RENAUD
Correspondent
Bioself, Inc.
C.P. 70
Saint-Lambert, Que. Canad, 
Correspondent Contact YVES RENAUD
Classification Product Code
LHD  
Date Received09/20/1984
Decision Date 12/04/1984
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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