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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 K190610
Device Name Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Applicant
Sterilmed, Inc.
5010 Cheshire Pkwy. N.
Suite 2
Plymouth,  MN  55446
Applicant Contact Jan Flegeau
Correspondent
Sterilmed, Inc.
5010 Cheshire Pkwy. N.
Suite 2
Plymouth,  MN  55446
Correspondent Contact Jan Flegeau
Classification Product Code
NLQ  
Date Received03/11/2019
Decision Date 08/15/2019
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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