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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 K895263
Device Name ILLUMINA MODEL 25, 40 AND 55 CO2 LASER SYSTEMS
Applicant
Heraeus Lasersonics, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035
Applicant Contact PAGE, BSRN
Correspondent
Heraeus Lasersonics, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035
Correspondent Contact PAGE, BSRN
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/23/1989
Decision Date 10/20/1989
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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