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510(k) K182545

Tamper Evident Cap with Male Luer Lock by International Medical Industries, Inc. — Product Code FPA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2019
Date Received
September 17, 2018
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 International Medical Industries, Inc.

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  • K173577 — Guarded Luer Connector (June 7, 2018)
  • K170672 — Tamper Evident Cap For use with ENFit Syringes (October 6, 2017)

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