FDA 510(k) Application Details - K222552

Device Classification Name Apparatus, Suction, Ward Use, Portable, Ac-Powered

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510(K) Number K222552
Device Name Apparatus, Suction, Ward Use, Portable, Ac-Powered
Applicant Stryker Instruments
1941 Stryker Way
Portage, MI 49002 US
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Contact Tu Nguyen
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Regulation Number 878.4780

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Classification Product Code JCX
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Date Received 08/23/2022
Decision Date 12/09/2022
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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