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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single-Use Reprocessed Ultrasonic Surgical Instruments
510(k) Number K143562
Device Name Reprocessed Cordless Ultrasonic Dissection Device
Applicant
Sterilmed, Inc.
11400 73rd Ave. N
Maple Grove,  MN  55369
Applicant Contact Nicole Boser
Correspondent
Libra Medical
8401 73rd Ave. N., Suite 63
Brooklyn Park,  MN  55448
Correspondent Contact JULIE BODMER
Classification Product Code
NLQ  
Date Received12/16/2014
Decision Date 05/20/2015
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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