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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 K094028
Device Name CP-FIBER (ORTHOFIBER)
Applicant
Cp Medical
803 NE 25th Ave.
Portland,  OR  97232
Applicant Contact BARBARA K HORTON
Correspondent
Cp Medical
803 NE 25th Ave.
Portland,  OR  97232
Correspondent Contact BARBARA K HORTON
Regulation Number878.5000
Classification Product Code
GAT  
Date Received12/30/2009
Decision Date 03/18/2010
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
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