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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name fab, rhodamine, antigen, antiserum, control
510(k) Number K013919
Device Name TORFLEX TRANSSEPTAL GUIDING SHEATH
Applicant
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO,  CA L4W-4T7
Applicant Contact KRIS SHAH
Correspondent
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO,  CA L4W-4T7
Correspondent Contact KRIS SHAH
Regulation Number866.5520
Classification Product Code
DBY  
Date Received11/27/2001
Decision Date 02/22/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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