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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 K041894
Device Name ORTHOFIBER
Applicant
Cp Medical
803 NE 25th Ave.
Portland,  OR  97232
Applicant Contact MARY ANN GREENAWALT
Correspondent
Cp Medical
803 NE 25th Ave.
Portland,  OR  97232
Correspondent Contact MARY ANN GREENAWALT
Regulation Number878.5000
Classification Product Code
GAT  
Date Received07/13/2004
Decision Date 09/17/2004
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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