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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 K882365
Device Name HERAEUS LASERSONICS ND:YAG LASER, MODEL 4900
Applicant
Heraeus Lasersonics, Inc.
3420 Central Expy.
P.O. Box 58005
Santa Clara,  CA  95051
Applicant Contact CAROL KIM
Correspondent
Heraeus Lasersonics, Inc.
3420 Central Expy.
P.O. Box 58005
Santa Clara,  CA  95051
Correspondent Contact CAROL KIM
Regulation Number878.4810
Classification Product Code
GEX  
Date Received06/08/1988
Decision Date 09/02/1988
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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