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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K142903
Device Name neoClose 2 AutoAnchor Pack US, neoClose 4 AutoAnchor Pack US
Applicant
Neosurgical, Ltd.
Block 12
Galway Technology Park, Parkmore
Galway,  IE EI
Applicant Contact Oria Brennan
Correspondent
Neosurgical, Ltd.
Block 12
Galway Technology Park, Parkmore
Galway,  IE EI
Correspondent Contact Oria Brennan
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/06/2014
Decision Date 11/12/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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