VACURECT VACUUM CONSTRICTION DEVICE

Device, External Penile Rigidity

VACURECT MANUFACTURING (PTY) LTD.

The following data is part of a premarket notification filed by Vacurect Manufacturing (pty) Ltd. with the FDA for Vacurect Vacuum Constriction Device.

Pre-market Notification Details

Device IDK032776
510k NumberK032776
Device Name:VACURECT VACUUM CONSTRICTION DEVICE
ClassificationDevice, External Penile Rigidity
Applicant VACURECT MANUFACTURING (PTY) LTD. 49 PLAIN ST. North Attleboro,  MA  02760
ContactMary Mcnamara-cullinane
CorrespondentMary Mcnamara-cullinane
VACURECT MANUFACTURING (PTY) LTD. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeLKY  
CFR Regulation Number876.5020 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-09-08
Decision Date2003-10-03
Summary:summary

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