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510(k) K112734

APLAN A.V. FISTULA NEEDLE SET by Aplan Well Enterprise Co., Ltd. — Product Code FIE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2012
Date Received
September 20, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Fistula
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

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