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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 K842703
Device Name ND-YAG LASER 8000 NEUROSURGERY APPLICA
Applicant
Cooper Lasersonics, Inc.
3420 Central Expy. .
Santa Clara,  CA  95051
Applicant Contact CHARLES L ROSE
Correspondent
Cooper Lasersonics, Inc.
3420 Central Expy. .
Santa Clara,  CA  95051
Correspondent Contact CHARLES L ROSE
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/11/1984
Decision Date 10/31/1984
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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