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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, neurosurgical fragmentation and aspiration
510(k) Number K884412
Device Name CUSA SYSTEM 200C,T & M ULTRASONIC SURGICAL ASPIRA.
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 General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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