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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tissue Expander And Accessories
510(k) Number K161483
Device Name Unger Quad Injector
Applicant
Stradis Healthcare
805 Marathon Pkwy.
Suite 100
Lawrenceville,  GA  30046
Applicant Contact Joseph Trznadel
Correspondent
Wood Burditt Group
10 E Scranton Ave., Suite 201
Lake Bluff,  IL  60044
Correspondent Contact H. Carl Jenkins
Classification Product Code
LCJ  
Date Received05/31/2016
Decision Date 10/31/2016
Decision Substantially Equivalent (SESE)
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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