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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Motor, Drill, Pneumatic
510(k) Number K042974
Device Name MEDICON VIPAIR HIGH SPEED SYSTEM
Applicant
Medicon Eg
Gaensaecker 15
Tuttlingen,  DE D-78532
Applicant Contact JOACHIM SCHMID
Correspondent
Medicon Eg
Gaensaecker 15
Tuttlingen,  DE D-78532
Correspondent Contact JOACHIM SCHMID
Regulation Number882.4370
Classification Product Code
HBB  
Date Received10/28/2004
Decision Date 01/13/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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