INTRAUTERINE CATHETER AND INTRODUCER

Cannula, Intrauterine Insemination

CONCEPTUS, INC.

The following data is part of a premarket notification filed by Conceptus, Inc. with the FDA for Intrauterine Catheter And Introducer.

Pre-market Notification Details

Device IDK932993
510k NumberK932993
Device Name:INTRAUTERINE CATHETER AND INTRODUCER
ClassificationCannula, Intrauterine Insemination
Applicant CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos,  CA  94070
ContactAlexis Ball
CorrespondentAlexis Ball
CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos,  CA  94070
Product CodeMFD  
CFR Regulation Number884.5250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-06-18
Decision Date1995-01-06

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