FDA 510(k) Application Details - K213274

Device Classification Name Container, Sharps

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510(K) Number K213274
Device Name Container, Sharps
Applicant Qlicksmart Pty Ltd.
Level 1, 148 Boundary Street, West End
Brisbane 4101 AU
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Contact Michael Sinnott
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Regulation Number 880.5570

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Classification Product Code MMK
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Date Received 09/30/2021
Decision Date 06/22/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Abbreviated
Reviewed By Third Party N
Expedited Review

FDA Source Information for K213274


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