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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 K261245
Device Name Restrata
Applicant
Acera Surgical, Inc.
1650 Des Peres Rd.
Suite 120
St. Louis,  MO  63131
Applicant Contact Tamas Kovacs
Correspondent
Acera Surgical, Inc.
1650 Des Peres Rd.
Suite 120
St. Louis,  MO  63131
Correspondent Contact Tamas Kovacs
Classification Product Code
QSZ  
Date Received04/16/2026
Decision Date 10/16/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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