FDA 510(k) Applications for Medical Device Product Code "QSZ"

FDA 510(k) Number Applicant Device Name Decision Date
K170300 Acera Surgical, Inc. Restrata Wound Matrix 04/26/2017
K193583 Acera Surgical, Inc. Restrata« 09/25/2020
K031684 BIOMET MERCK GMBH TOPKIN WOUND DRESSING 10/30/2003
K161067 ENGINEERED TISSUE SOLUTIONS, LLC Mirragen Advanced Wound Matrix, 4x4ö, Mirragen Advanced Wound Matrix, 2x2ö, Mirragen Advanced Wound Matrix, 1x6ö 09/15/2016
K173544 Nanofiber Solutions, Inc. Phoenix Wound Matrix 03/02/2018
K170213 PolyMedics Innovations GmbH SupraSDRM Biodegradable Matrix Wound Dressing 06/28/2017
K090160 POLYMEDICS INNOVATIONS GMBH SUPRATHEL WOUND AND BURN DRESSING 05/20/2009
K142879 POLYNOVO BIOMATERIALS PTY LTD BTM Wound Dressing 12/23/2015
K172140 PolyNovo Biomaterials Pty Ltd NovoSorb BTM Wound Dressing (2cm x 2cm), NovoSorb BTM Wound Dressing (10cm x 10cm), NovoSorb BTM Wound Dressing (10cm x 20cm), NovoSorb BTM Wound Dressing (20cm x 40cm) 08/11/2017
K221686 PolyNovo Biomaterials Pty Ltd NovoSorb Matrix 09/15/2022
K132397 W. L. GORE & ASSOCIATES, INC. GORE BIO-A WOUND MATRIX 05/07/2014


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