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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Airbrush
510(k) Number K042872
Device Name RONDOFLEX PLUS 360
Applicant
Kavo America Corporation
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Kavo America Corporation
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number872.6080
Classification Product Code
KOJ  
Date Received10/18/2004
Decision Date 11/23/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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