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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorbable Synthetic Wound Dressing
510(k) Number K170300
Device Name Restrata Wound Matrix
Applicant
Acera Surgical, Inc.
10880 Baur Blvd.
St. Louis,  MO  63132
Applicant Contact Tamas Kovacs
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Classification Product Code
QSZ  
Date Received01/31/2017
Decision Date 04/26/2017
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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