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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Suture, Absorbable, Synthetic, Polyglycolic Acid
510(k) Number K120556
Device Name VILET VILET QUICK
Applicant
Riverpoint Medical
825 NE 25th Ave.
Portland,  OR  97232
Applicant Contact DOUG ROWLEY
Correspondent
Riverpoint Medical
825 NE 25th Ave.
Portland,  OR  97232
Correspondent Contact DOUG ROWLEY
Regulation Number878.4493
Classification Product Code
GAM  
Date Received02/24/2012
Decision Date 05/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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