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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 K223725
Device Name Restrata® MiniMatrix
Applicant
Acera Surgical, Inc.
1650 Des Peres Rd.
Suite 120
St. Louis,  MO  63131
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 Received12/13/2022
Decision Date 05/18/2023
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
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