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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 K173272
Device Name Ergonomic Handle
Applicant
Symmetry Surgical, Inc.
3034 Owen Dr.
Antioch,  TN  37013
Applicant Contact Christopher Smith
Correspondent
Symmetry Surgical, Inc.
3034 Owen Dr.
Antioch,  TN  37013
Correspondent Contact Christopher Smith
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received10/12/2017
Decision Date 02/09/2018
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
Predetermined Change
Control Plan Authorized		 No
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