Miromatrix Biological Mesh RS

Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery

MIROMATRIX MEDICAL INC.

The following data is part of a premarket notification filed by Miromatrix Medical Inc. with the FDA for Miromatrix Biological Mesh Rs.

Pre-market Notification Details

Device IDK150341
510k NumberK150341
Device Name:Miromatrix Biological Mesh RS
ClassificationMesh, Surgical, Collagen, Plastic And Reconstructive Surgery
Applicant MIROMATRIX MEDICAL INC. 18683 Bearpath Trail Eden Prairie,  MN  55347
ContactJeff Ross
CorrespondentMiriam C. Provost
BIOLOGICS CONSULTING GROUP, INC. 400 N. WASHINGTON STREET SUITE 100 Alexandria,  VA  22314
Product CodeOXH  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-02-11
Decision Date2015-05-12
Summary:summary

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