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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 K012571
Device Name REPROCESSED HARMONIC
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Applicant Contact PATRICK FLEISCHHACKER
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Correspondent Contact PATRICK FLEISCHHACKER
Classification Product Code
NLQ  
Date Received08/09/2001
Decision Date 11/07/2001
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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