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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K032805
Device Name MODIFICATION TO VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
Applicant
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis,  MN  55369
Applicant Contact DEBORAH JENSEN
Correspondent
Vascular Solutions, Inc.
6464 Sycamore Court
Minneapolis,  MN  55369
Correspondent Contact DEBORAH JENSEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/09/2003
Decision Date 10/01/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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