FDA 510(k) Application Details - K230255

Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories

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510(K) Number K230255
Device Name Electrosurgical, Cutting & Coagulation & Accessories
Applicant Stryker Sustainability Solutions
1810 W Drake Drive
Tempe, AZ 85283 US
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Contact Scott English
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Regulation Number 878.4400

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Classification Product Code GEI
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Date Received 01/31/2023
Decision Date 03/28/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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