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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 K113140
Device Name VARI-LASE WIREFIBER LASER FIBER
Applicant
VASCULAR SOLUTIONS, INC.
6464 Sycamore Court North
Minneapolis,  MN  55369
Applicant Contact JENIFER RUETHER
Correspondent
VASCULAR SOLUTIONS, INC.
6464 Sycamore Court North
Minneapolis,  MN  55369
Correspondent Contact JENIFER RUETHER
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/25/2011
Decision Date 12/22/2011
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
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