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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 K101784
Device Name MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX
Applicant
Great Batch Medical
2300 Berkshire Ln. N.
Plymouth,  MN  55441
Applicant Contact Kristi Fox
Correspondent
Great Batch Medical
2300 Berkshire Ln. N.
Plymouth,  MN  55441
Correspondent Contact Kristi Fox
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/25/2010
Decision Date 11/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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