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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 K002172
Device Name POLY-TAPES (VARIOUS SIZES AND WOVEN CONSTRUCTION VARIANTS)
Applicant
XIROS PLC
28-30 BLENHEIM TERRACE
LEEDS,  GB LS2 9HD
Applicant Contact JIM ROWLAND
Correspondent
XIROS PLC
28-30 BLENHEIM TERRACE
LEEDS,  GB LS2 9HD
Correspondent Contact JIM ROWLAND
Regulation Number878.5000
Classification Product Code
GAT  
Date Received07/19/2000
Decision Date 08/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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