FDA 510(k) Application Details - K202964

Device Classification Name Bed, Ac-Powered Adjustable Hospital

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510(K) Number K202964
Device Name Bed, Ac-Powered Adjustable Hospital
Applicant Stryker Corporation
3800 E. Centre Avenue
Portage, MI 49002 US
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Contact Cathy Friday
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Regulation Number 880.5100

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Classification Product Code FNL
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Date Received 09/30/2020
Decision Date 06/18/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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