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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 K895279
Device Name LASERMATIC COMBOLASER MODEL 5050
Applicant
Lasermatic OY
45 W. St.
Suite 2
North Attleboro,  MA  02760
Applicant Contact FULLER W MORTON
Correspondent
Lasermatic OY
45 W. St.
Suite 2
North Attleboro,  MA  02760
Correspondent Contact FULLER W MORTON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/24/1989
Decision Date 11/08/1989
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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