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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 K895363
Device Name BIOVISION EMERALD LASER PHOTOCOAGULATOR
Applicant
F.I.T. of France
100 Hegenberger Rd.,
Suite 210
Oakland,  CA  94621
Applicant Contact DOUGLAS DONALDSON
Correspondent
F.I.T. of France
100 Hegenberger Rd.,
Suite 210
Oakland,  CA  94621
Correspondent Contact DOUGLAS DONALDSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/28/1989
Decision Date 06/24/1991
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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