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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 K131688
Device Name NEOCLOSE HASSON, NEOCLOSE UNIVERSAL
Applicant
NEOSURGICAL LTD
BLOCK 12
GALWAY TECHNOLOGY PARK, PARKMORE
GALWAY,  IE EI
Applicant Contact ORLA BRENNAN
Correspondent
NEOSURGICAL LTD
BLOCK 12
GALWAY TECHNOLOGY PARK, PARKMORE
GALWAY,  IE EI
Correspondent Contact ORLA BRENNAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received06/10/2013
Decision Date 07/18/2013
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
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