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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 K100006
Device Name HS FIBER (POLYBLEND), RIVER BOND, RIVERSILK (SILK), RIVERPRO (POLYPROPYLENE), RIVERLON (NYLON) MODEL VERIES BY SIZE/NEED
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 Number878.5000
Classification Product Code
GAT  
Subsequent Product Codes
GAP   GAR   GAS   GAW  
Date Received01/04/2010
Decision Date 05/10/2010
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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