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510(k) K112541

Z FLEX-270TM STEERABLE SHEATH by Great Batch Medical — Product Code DRA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 7, 2012
Date Received
September 1, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Steerable
Device Class
Class II
Regulation Number
870.1280
Review Panel
CV
Submission Type

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