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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, E.G.
GAENSAECKER 15
TUTTLINGEN,  DE D-78532
Applicant Contact JOACHIM SCHMID
Correspondent
MEDICON, E.G.
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
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