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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 K050343
Device Name REPROCESSED HARMONIC SCALPELS
Applicant
STERILMED, INC.
11400 73RD. AVE. N. STE. 100
MAPLE GROVE,  MN  55369
Applicant Contact BRUCE LESTER
Correspondent
STERILMED, INC.
11400 73RD. AVE. N. STE. 100
MAPLE GROVE,  MN  55369
Correspondent Contact BRUCE LESTER
Classification Product Code
NLQ  
Date Received02/11/2005
Decision Date 04/12/2005
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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