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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 K904067
Device Name LASERSAT CO2
Applicant
Satelec
Z.I. Du Phare, Bp 216
17 Ave. Gustave Eiffel
Merignac,  FR 33708
Applicant Contact DUPEYRON
Correspondent
Satelec
Z.I. Du Phare, Bp 216
17 Ave. Gustave Eiffel
Merignac,  FR 33708
Correspondent Contact DUPEYRON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/31/1990
Decision Date 11/07/1990
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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