FDA 510(k) Application Details - K222818

Device Classification Name Transport, Patient, Powered

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510(K) Number K222818
Device Name Transport, Patient, Powered
Applicant Stryker Medical
3800 E. Centre Ave.
Portage, MI 49002 US
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Contact Rachel Stallworth
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Regulation Number 890.5150

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Classification Product Code ILK
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Date Received 09/19/2022
Decision Date 01/24/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee PM - Physical Medicine
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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