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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K152111
FOIA Releasable 510(k) K152111
Device Name Symmetry Surgical Quad-Lock Container System
Applicant
Symmetry Surgical, Inc.
334 Owen Dr.
Antioch,  TN  37013
Applicant Contact LORA TJOMSTOL
Correspondent
Lakeshore Medical Device Consulting, LLC
128 Blye Hill Landing
Newbury,  NH  03255
Correspondent Contact MICHELE LUCEY
Regulation Number880.6850
Classification Product Code
KCT  
Date Received07/29/2015
Decision Date 04/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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