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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 K941838
Device Name MULTIPLE CO2 LAERS
Applicant
Mattioli Engineering, Srl
Viale Machiavelli, 2/A
Florence,  IT 50125
Applicant Contact GIAN FRANCO BERNABEI
Correspondent
Mattioli Engineering, Srl
Viale Machiavelli, 2/A
Florence,  IT 50125
Correspondent Contact GIAN FRANCO BERNABEI
Regulation Number878.4810
Classification Product Code
GEX  
Date Received04/13/1994
Decision Date 12/15/1994
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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