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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 K162310
Device Name XBraid TT Suture Tape
Applicant
Stryker
5670 Greenwood Plaza Blvd., Suite 200
Greenwood Village,  CO  80111
Applicant Contact Taylor White
Correspondent
Stryker
5670 Greenwood Plaza Blvd., Suite 200
Greenwood Village,  CO  80111
Correspondent Contact Taylor White
Regulation Number878.5000
Classification Product Code
GAT  
Date Received08/17/2016
Decision Date 11/10/2016
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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