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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Nonabsorbable, Synthetic, Polyethylene
510(k) Number K230311
Device Name HyperSuture
Applicant
Threadstone, LLC
1035 Benfield Blvd.
Suite H
Millersville,  MD  21108
Applicant Contact Jeremy Clark
Correspondent
Threadstone, LLC
1035 Benfield Blvd.
Suite H
Millersville,  MD  21108
Correspondent Contact Jeremy Clark
Regulation Number878.5000
Classification Product Code
GAT  
Date Received02/03/2023
Decision Date 11/24/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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