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510(k) K981329

FETH-R-KATH by Epimed International, Inc. — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 1998
Date Received
April 13, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type

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