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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name neurosurgical ultrasonic instruments
510(k) Number K853143
Device Name COOPER LASER SONICS CUSA MODEL 200
Applicant
COOPER LASERSONICS, INC.
3420 Central Expressway
Santa Clara,  CA  95051
Applicant Contact CHARLES L ROSE
Correspondent
COOPER LASERSONICS, INC.
3420 Central Expressway
Santa Clara,  CA  95051
Correspondent Contact CHARLES L ROSE
Classification Product Code
LBK  
Date Received07/29/1985
Decision Date 10/16/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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