NEWPORT LATERAL VAGINAL RETRACTOR

Instrument, Manual, General Obstetric-gynecologic

SIMPSON/BASYE, INC.

The following data is part of a premarket notification filed by Simpson/basye, Inc. with the FDA for Newport Lateral Vaginal Retractor.

Pre-market Notification Details

Device IDK891351
510k NumberK891351
Device Name:NEWPORT LATERAL VAGINAL RETRACTOR
ClassificationInstrument, Manual, General Obstetric-gynecologic
Applicant SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington,  DE  19804
ContactRobert A Basye
CorrespondentRobert A Basye
SIMPSON/BASYE, INC. 430 AYRE ST. Wilmington,  DE  19804
Product CodeKOH  
CFR Regulation Number884.4520 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-03-10
Decision Date1989-05-11

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