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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Instrument, Ultrasonic Surgical
510(k) Number K801623
Device Name CAVITRON ULTRASONIC SURG. ASPIR. CUSA
Applicant
Cavitron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Cavitron Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Classification Product Code
LFL  
Date Received07/15/1980
Decision Date 11/18/1980
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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