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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 K132566
Device Name REPROCESSED HARMONIC SHEAR
Applicant
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Applicant Contact SKRAMSTED
Correspondent
STERILMED, INC.
11400 73RD AVE. NORTH
MAPLE GROVE,  MN  55369
Correspondent Contact SKRAMSTED
Classification Product Code
NLQ  
Date Received08/15/2013
Decision Date 06/14/2014
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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