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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 K030654
Device Name VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT
Applicant
VASCULAR SOLUTIONS, INC.
2495 XENIUM LN. NORTH
MINNEAPOLIS,  MN  55441
Applicant Contact DEBORAH JENSEN
Correspondent
VASCULAR SOLUTIONS, INC.
2495 XENIUM LN. NORTH
MINNEAPOLIS,  MN  55441
Correspondent Contact DEBORAH JENSEN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/03/2003
Decision Date 06/18/2003
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
Recalls CDRH Recalls
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