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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 K182434
Device Name LaparoGuard
Applicant
Mariner Endosurgery Inc.
305A, 175 Longwood Road South
Hamilton,  CA L8P 0A1
Applicant Contact Mitch Wilson
Correspondent
Ironstone Product Development Inc.
Suite 222, 276 Carlaw Ave
Toronto,  CA M4M 3L1
Correspondent Contact Joel Ironstone
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received09/06/2018
Decision Date 12/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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