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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 K904610
Device Name HERCULES MODEL 5000 AND 5040 ND:YAG LASER SYSTEMS
Applicant
Heraeus Lasersonics, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035
Applicant Contact LISA MCGRATH
Correspondent
Heraeus Lasersonics, Inc.
575 Cottonwood Dr.
Milpitas,  CA  95035
Correspondent Contact LISA MCGRATH
Regulation Number878.4810
Classification Product Code
GEX  
Date Received10/11/1990
Decision Date 12/19/1990
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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