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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 K153307
Device Name HS SutureTape
Applicant
RIVERPOINT MEDICAL
825 NE 25th Avenue
Portland,  OR  97232
Applicant Contact Edwin Anderson
Correspondent
RIVERPOINT MEDICAL
825 NE 25th Avenue
Portland,  OR  97232
Correspondent Contact Edwin Anderson
Regulation Number878.5000
Classification Product Code
GAT  
Date Received11/16/2015
Decision Date 02/12/2016
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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