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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 K952045
Device Name LMT 20 HH LASER SURGIVAL SYSTEM
Applicant
Laser Max Medical Technologies Corp.
24630 Blue Dane Ln.
Malibu,  CA  90265
Applicant Contact PAUL Y FANG
Correspondent
Laser Max Medical Technologies Corp.
24630 Blue Dane Ln.
Malibu,  CA  90265
Correspondent Contact PAUL Y FANG
Regulation Number878.4810
Classification Product Code
GEX  
Date Received05/01/1995
Decision Date 10/03/1995
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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