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510(k) K081052

OCCLUSION BALLOON CATHETER, MODEL VENOS by Oscor, Inc. — Product Code DYG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2008
Date Received
April 14, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Flow Directed
Device Class
Class II
Regulation Number
870.1240
Review Panel
CV
Submission Type

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