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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name staple, implantable
510(k) Number K173270
Device Name Tri-Staple 2.0 Reinforced Reload
60 Middletown Ave.
north haven,  CT  06473
Applicant Contact rebecca magnanimo
60 Middletown Ave.
north haven,  CT  06473
Correspondent Contact rebecca magnanimo
Regulation Number878.4750
Classification Product Code
Subsequent Product Code
Date Received10/12/2017
Decision Date 02/20/2018
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
Recalls CDRH Recalls