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510(k) K091306

AMSURE PVC INTERMITTENT CATHETER by Amsino International, Inc. — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2009
Date Received
May 4, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Straight
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

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