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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 K895430
Device Name HERAEUS LASERSONICS ND:YAG LASER, MODEL LUXUS 100
Applicant
Heraeus Lasersonics, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035
Applicant Contact DONNA J PAGE
Correspondent
Heraeus Lasersonics, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035
Correspondent Contact DONNA J PAGE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/05/1989
Decision Date 11/28/1989
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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