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510(k) K191640

TK Intravascular Administration Set by Anhui Tiankang Medical Technology Co., Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2020
Date Received
June 19, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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