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510(k) K091699

AMSURE HYDROPHILIC LATEX FOLEY CATHETER by Amsino International, Inc. — Product Code EZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2009
Date Received
June 10, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

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