RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)

Cannula, Suction, Uterine

WOMANCARE GLOBAL

The following data is part of a premarket notification filed by Womancare Global with the FDA for Rigid Cannulae Curved (rc6-rc12), Rigid Cannulae Straight (rs6-rs12).

Pre-market Notification Details

Device IDK093508
510k NumberK093508
Device Name:RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12)
ClassificationCannula, Suction, Uterine
Applicant WOMANCARE GLOBAL 300 MARKET ST. SUITE 134 Chapel Hill,  NC  27516
ContactSusanne Parks
CorrespondentSusanne Parks
WOMANCARE GLOBAL 300 MARKET ST. SUITE 134 Chapel Hill,  NC  27516
Product CodeHGH  
CFR Regulation Number884.5070 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-11-12
Decision Date2010-03-04
Summary:summary

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