IOB DISPOSABLE SPECULUM

Speculum, Vaginal, Nonmetal

IOB MEDICAL INC

The following data is part of a premarket notification filed by Iob Medical Inc with the FDA for Iob Disposable Speculum.

Pre-market Notification Details

Device IDK132668
510k NumberK132668
Device Name:IOB DISPOSABLE SPECULUM
ClassificationSpeculum, Vaginal, Nonmetal
Applicant IOB MEDICAL INC 504E DIAMOND AVE. SUITE F Gaithersburg,  MD  20877
ContactJoe Xia
CorrespondentJoe Xia
IOB MEDICAL INC 504E DIAMOND AVE. SUITE F Gaithersburg,  MD  20877
Product CodeHIB  
CFR Regulation Number884.4530 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-27
Decision Date2014-01-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06951013000416 K132668 000
06951013000409 K132668 000
06951013000393 K132668 000

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