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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 K921096
Device Name LASER-6
Applicant
Laser Endo Technic
981 Calle Amanecer
San Clements,  CA  92672
Applicant Contact PHILIPPE C LEVY
Correspondent
Laser Endo Technic
981 Calle Amanecer
San Clements,  CA  92672
Correspondent Contact PHILIPPE C LEVY
Regulation Number878.4810
Classification Product Code
GEX  
Date Received03/09/1992
Decision Date 07/28/1992
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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