NON-STERILE DISPOSABLE VAGINAL SPECULUM

Speculum, Vaginal, Nonmetal

KUNSHAN DEYI PLASTIC CO., LTD.

The following data is part of a premarket notification filed by Kunshan Deyi Plastic Co., Ltd. with the FDA for Non-sterile Disposable Vaginal Speculum.

Pre-market Notification Details

Device IDK092870
510k NumberK092870
Device Name:NON-STERILE DISPOSABLE VAGINAL SPECULUM
ClassificationSpeculum, Vaginal, Nonmetal
Applicant KUNSHAN DEYI PLASTIC CO., LTD. 77325 JOYCE WAY Echo,  OR  97826
ContactCharlie Mack
CorrespondentCharlie Mack
KUNSHAN DEYI PLASTIC CO., LTD. 77325 JOYCE WAY Echo,  OR  97826
Product CodeHIB  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-09-18
Decision Date2010-02-16
Summary:summary

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