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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name laser, neurosurgical
510(k) Number K844440
Device Name MODEL 4000 ND:YAG LASER FOR HEMORRHAGE CONTROL
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
LKW  
Date Received11/16/1984
Decision Date 05/09/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
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