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510(k) K102540

PTFE PORTABLE INTRODUCER by Great Batch Medical — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 2010
Date Received
September 3, 2010
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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