XSTAT

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

REVMEDX, INC.

The following data is part of a De Novo classification by Revmedx, Inc. with the FDA for Xstat.

Pre-market Notification Details

DeNovo IDDEN130016
Device Name:XSTAT
ClassificationNon-absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use
Applicant REVMEDX, INC. 555 13th Street Nw Washington,  DC  20004
ContactJohn J Smith
Product CodePGZ  
CFR Regulation Number878.4452 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK130218
Review Advisory BoardGeneral & Plastic Surgery
Classification AdvisoryGeneral & Plastic Surgery
TypeDirect
Date Received2013-01-30
Decision Date2014-04-03
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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