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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 K012923
Device Name ARTHREX FIBERWIRE, USP SIZE 5, MODEL AR-7201
Applicant
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES,  FL  34104
Applicant Contact ANN WATERHOUSE
Correspondent
ARTHREX, INC.
2885 SOUTH HORSESHOE DR.
NAPLES,  FL  34104
Correspondent Contact ANN WATERHOUSE
Regulation Number878.5000
Classification Product Code
GAT  
Date Received08/31/2001
Decision Date 10/04/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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