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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 K202242
Device Name HS Fiber
Applicant
Riverpoint Medical, LLC
825 NE 25th Ave
Portland,  OR  97232
Applicant Contact Edwin Anderson
Correspondent
Riverpoint Medical, LLC
825 NE 25th Ave
Portland,  OR  97232
Correspondent Contact Edwin Anderson
Regulation Number878.5000
Classification Product Code
GAT  
Date Received08/10/2020
Decision Date 09/10/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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