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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 K231163
Device Name HS Fiber Sutures
Applicant
Riverpoint Medical
825 NE 25th Ave.
Portland,  OR  97232
Applicant Contact Paul Vagts
Correspondent
Riverpoint Medical
825 NE 25th Ave.
Portland,  OR  97232
Correspondent Contact Paul Vagts
Regulation Number878.5000
Classification Product Code
GAT  
Date Received04/24/2023
Decision Date 01/05/2024
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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