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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 K903079
Device Name ENDOGUIDE (R), MICROGUIDE (TM), FLEXIGUIDE (TM)
Applicant
Luxar Corp.
11816 N. Creek Pkwy. N.,
Suite 102
Bothell,  WA  98011
Applicant Contact KATHERINE LAAKMANN
Correspondent
Luxar Corp.
11816 N. Creek Pkwy. N.,
Suite 102
Bothell,  WA  98011
Correspondent Contact KATHERINE LAAKMANN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/12/1990
Decision Date 10/04/1990
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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