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510(k) K201460

Closed System Transfer Device by Shinva Ande Healthcare Apparatus Co., Ltd. — Product Code ONB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2022
Date Received
June 2, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Reconstitute and transfer antineoplastic and other hazardous drugs in healthcare setting indicated to reduce exposure of healthcare personnel to chemotherapy agents in healthcare setting.

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  • K162601 — Infusion Set for Single Use (May 31, 2017)

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