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510(k) K193192

Tamper Evident Cap by International Medical Industries, Inc. — Product Code FMF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 31, 2020
Date Received
November 19, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
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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