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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 K884413
Device Name CUSA SYSTEM 200H ULTRASONIC SURGICAL ASPIRATOR
Applicant
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Applicant Contact PEGGY WALLINE
Correspondent
Valleylab, Inc.
5920 Longbow Dr.
Boulder,  CO  80301
Correspondent Contact PEGGY WALLINE
Classification Product Code
LBK  
Date Received10/20/1988
Decision Date 12/02/1988
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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