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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 K083060
Device Name REPROCESSED HARMONIC SCALPEL
Applicant
Sterilmed, Inc.
11140 73rd Ave. N.
Maple Grove,  MN  55369
Applicant Contact DENNIS TOUSSAINT
Correspondent
Sterilmed, Inc.
11140 73rd Ave. N.
Maple Grove,  MN  55369
Correspondent Contact DENNIS TOUSSAINT
Classification Product Code
NLQ  
Subsequent Product Code
LFL  
Date Received10/14/2008
Decision Date 01/09/2009
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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