MODIFICATION TO URESTA PESSARY

Pessary, Vaginal

EASTMED INC.

The following data is part of a premarket notification filed by Eastmed Inc. with the FDA for Modification To Uresta Pessary.

Pre-market Notification Details

Device IDK083769
510k NumberK083769
Device Name:MODIFICATION TO URESTA PESSARY
ClassificationPessary, Vaginal
Applicant EASTMED INC. 4 INNOVATION DRIVE Dundas, Ontario,  CA L9h 7p3
ContactRoshana Ahmed
CorrespondentRoshana Ahmed
EASTMED INC. 4 INNOVATION DRIVE Dundas, Ontario,  CA L9h 7p3
Product CodeHHW  
CFR Regulation Number884.3575 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-12-18
Decision Date2009-01-14
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00692379000264 K083769 000
10692379000247 K083769 000
10692379000230 K083769 000
10692379000223 K083769 000
10692379000216 K083769 000
10692379000209 K083769 000

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