AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.

Monitor, Pressure, Intrauterine

SPECTRAMED, INC.

The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Amnicath(tm) Model Dt-iupc Trans. Tipped Intrau..

Pre-market Notification Details

Device IDK881857
510k NumberK881857
Device Name:AMNICATH(TM) MODEL DT-IUPC TRANS. TIPPED INTRAU.
ClassificationMonitor, Pressure, Intrauterine
Applicant SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
ContactRobert L Leavitt
CorrespondentRobert L Leavitt
SPECTRAMED, INC. 1900 WILLIAMS DR. Oxnard,  CA  93030
Product CodeKXO  
CFR Regulation Number884.2700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-03
Decision Date1989-02-01

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.