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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name scalpel, ultrasonic, reprocessed
510(k) Number K190610
Device Name Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
Applicant
Sterilmed, Inc.
5010 Cheshire Parkway N, Suite 2
plymouth,  MN  55446
Applicant Contact jan flegeau
Correspondent
Sterilmed, Inc.
5010 Cheshire Parkway 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
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