BIOSELF TM 110

Device, Fertility Diagnostic, Proceptive

BIOSELF, INC.

The following data is part of a premarket notification filed by Bioself, Inc. with the FDA for Bioself Tm 110.

Pre-market Notification Details

Device IDK843699
510k NumberK843699
Device Name:BIOSELF TM 110
ClassificationDevice, Fertility Diagnostic, Proceptive
Applicant BIOSELF, INC. C.P. 70 Saint-lambert, Que. Canad, 
ContactYves Renaud
CorrespondentYves Renaud
BIOSELF, INC. C.P. 70 Saint-lambert, Que. Canad, 
Product CodeLHD  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-20
Decision Date1984-12-04

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