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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 K910200
Device Name LASER-35
Applicant
Endo Technic Corp.
3002 Dow Ave., Suite 114
Tustin,  CA  92680
Applicant Contact PHILIPPE C LEVY
Correspondent
Endo Technic Corp.
3002 Dow Ave., Suite 114
Tustin,  CA  92680
Correspondent Contact PHILIPPE C LEVY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/15/1991
Decision Date 05/09/1991
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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