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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 K170957
Device Name ReConnex Pre-Sutured Tendon
Applicant
Allosource
6278 S. Troy Circle
Centennial,  CO  80111
Applicant Contact Pamela Vetter
Correspondent
Allosource
6278 S. Troy Circle
Centennial,  CO  80111
Correspondent Contact Trevor Wright
Regulation Number878.5000
Classification Product Code
GAT  
Date Received03/31/2017
Decision Date 03/20/2018
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
Predetermined Change
Control Plan Authorized		 No
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