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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Surgical, Absorbable, Polydioxanone
510(k) Number K252171
Device Name Barbed PDO Suture
Applicant
Sutura Medical Technology, Inc.
3 Allied Dr.
Suite 210
Dedham,  MA  02026
Applicant Contact Annie Kim
Correspondent
Health Policy and Associates
3 Allied Dr.
Suite 210
Dedham,  MA  02026
Correspondent Contact Annie Kim
Regulation Number878.4840
Classification Product Code
NEW  
Date Received07/10/2025
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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