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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K101117
Device Name LEV-OR DILATION CATHETER OTW
Original Applicant
BAYLIS MEDICAL CO., INC.
2645 matheson blvd. e
mississauga, ontario,  CA l4w 5s4
Original Contact meghal khakhar
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/21/2010
Decision Date 07/16/2010
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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