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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 K193583
Device Name Restrata®
Applicant
Acera Surgical, Inc.
10880 Baur Blvd.
St. Louis,  MO  63132
Applicant Contact Lily Jeng
Correspondent
Secure Biomed Evalutations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Classification Product Code
QSZ  
Date Received12/23/2019
Decision Date 09/25/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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