CERVICAL CATHETER

Cannula, Manipulator/injector, Uterine

CONCEPTUS, INC.

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

Pre-market Notification Details

Device IDK933981
510k NumberK933981
Device Name:CERVICAL CATHETER
ClassificationCannula, Manipulator/injector, Uterine
Applicant CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos,  CA  94070
ContactAlexis Ball
CorrespondentAlexis Ball
CONCEPTUS, INC. 1021 HOWARD AVE. San Carlos,  CA  94070
Product CodeLKF  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-16
Decision Date1994-12-27

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