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510(k) K130559

MOBICATH BI-DIRECTIONAL GUIDING SHEATH by Great Batch Medical — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2013
Date Received
March 4, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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