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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 K050021
Device Name VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
Applicant
VASCULAR SOLUTIONS, INC.
6464 SYCAMORE COURT
MINNEAPOLIS,  MN  55369
Applicant Contact LINDA BUSKLEIN
Correspondent
VASCULAR SOLUTIONS, INC.
6464 SYCAMORE COURT
MINNEAPOLIS,  MN  55369
Correspondent Contact LINDA BUSKLEIN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/05/2005
Decision Date 03/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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