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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
Applicant
BAYLIS MEDICAL CO., INC.
2645 MATHESON BLVD. E
MISSISSAUGA, ONTARIO,  CA L4W 5S4
Applicant Contact MEGHAL KHAKHAR
Correspondent
BAYLIS MEDICAL CO., INC.
2645 MATHESON BLVD. E
MISSISSAUGA, ONTARIO,  CA L4W 5S4
Correspondent Contact MEGHAL KHAKHAR
Regulation Number870.1250
Classification Product Code
DQY  
Date Received04/21/2010
Decision Date 07/16/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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