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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 K943716
Device Name LASERSONICS SURGICAL LASER SYSTEMS AND ACCESSORIES
Applicant
Heraeus Surgical, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035 -7434
Applicant Contact LISA MCGRATH
Correspondent
Heraeus Surgical, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035 -7434
Correspondent Contact LISA MCGRATH
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/01/1994
Decision Date 03/14/1995
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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