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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 K000158
Device Name VEINLASE, MODEL E50-K8-B5, SPECTRUM K8, MODEL E50-K8-B9
Applicant
FISMA, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Applicant Contact DOUGLAS A KANE
Correspondent
FISMA, INC.
3959 WEST 1820 SOUTH
SALT LAKE CITY,  UT  84104
Correspondent Contact DOUGLAS A KANE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/19/2000
Decision Date 08/24/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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