IMAGYN FALLOPOSCOPY SYSTEM

Falloposcope

IMAGYN MEDICAL, INC.

The following data is part of a premarket notification filed by Imagyn Medical, Inc. with the FDA for Imagyn Falloposcopy System.

Pre-market Notification Details

Device IDK963580
510k NumberK963580
Device Name:IMAGYN FALLOPOSCOPY SYSTEM
ClassificationFalloposcope
Applicant IMAGYN MEDICAL, INC. 27651 LA PAZ RD. Laguna Niguel,  CA  92656 -3917
ContactDebra A Rinderer
CorrespondentDebra A Rinderer
IMAGYN MEDICAL, INC. 27651 LA PAZ RD. Laguna Niguel,  CA  92656 -3917
Product CodeMKO  
CFR Regulation Number884.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-09-06
Decision Date1997-01-31
Summary:summary

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