XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack

Non-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

RevMedx, Inc.

The following data is part of a premarket notification filed by Revmedx, Inc. with the FDA for Xstat 30, 3-pack; Xstat 30, 1-pack; Xstat 12, 3 Pack; Xstat 12, 1 Pack.

Pre-market Notification Details

Device IDK170334
510k NumberK170334
Device Name:XSTAT 30, 3-Pack; XSTAT 30, 1-Pack; XSTAT 12, 3 Pack; XSTAT 12, 1 Pack
ClassificationNon-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Applicant RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville,  OR  97070
ContactAmy K. Pointer
CorrespondentAmy K. Pointer
RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville,  OR  97070
Product CodePGZ  
CFR Regulation Number878.4452 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-02
Decision Date2017-05-01
Summary:summary

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