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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 K883522
Device Name AMERIMED ULTRASONIC SURGICAL ASPIRATION KIT
Applicant
Amerimed US Corp.
777 Grant, Suite 305
Denver,  CO  80203
Applicant Contact TODD C CUSHMAN
Correspondent
Amerimed US Corp.
777 Grant, Suite 305
Denver,  CO  80203
Correspondent Contact TODD C CUSHMAN
Classification Product Code
LBK  
Date Received08/17/1988
Decision Date 09/30/1988
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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