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510(k) K202437

Infusion Sets for Single Use by Jiangsu Suyun Medical Materials Co., Ltd. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2022
Date Received
August 25, 2020
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

Other clearances by Jiangsu Suyun Medical Materials Co., Ltd.

  • K102847 — DISPOSABLE ENDOMETRIAL SUCTION CURETTE (April 14, 2011)

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