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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, Polyamide
510(k) Number K152795
Device Name RiverLon (Nylon) Suture
Applicant
Riverpoint Medical
825 NE 25th Ave.
Portland,  OR  97232
Applicant Contact Edwin Anderson
Correspondent
Riverpoint Medical
825 NE 25th Ave.
Portland,  OR  97232
Correspondent Contact Edwin Anderson
Regulation Number878.5020
Classification Product Code
GAR  
Date Received09/28/2015
Decision Date 10/28/2015
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
Predetermined Change
Control Plan Authorized		 No
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