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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K131079
Device Name CREGANNA-TACTX STEERABLE SHEATH SET SYMMETRIC
Applicant
CREGANNA MEDICAL DEVICES
386 WEST MAIN STREET SUITE 7
NORTHBOROUGH,  MA  01532
Applicant Contact CHRISTINE NICHOLS
Correspondent
CREGANNA MEDICAL DEVICES
386 WEST MAIN STREET SUITE 7
NORTHBOROUGH,  MA  01532
Correspondent Contact CHRISTINE NICHOLS
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/17/2013
Decision Date 08/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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