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510(k) K132899

EQUASHIELD CLOSED SYSTEM DRUG TRANSFER DEVICE (CSTD) by Equashield Medical , Ltd. — Product Code ONB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 13, 2014
Date Received
September 16, 2013
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.

Other clearances by Equashield Medical , Ltd.

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  • K170706 — Equashield Closed System drug Transfer Device (CSTD) (July 3, 2017)
  • K150219 — Equashield Closed System drug Transfer Device (CSTD) (November 5, 2015)
  • K101940 — EQUASHIELD SYSTEM PROTECTIVE PLUS (November 19, 2010)

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