FDA 510(k) Application Details - K230733

Device Classification Name Plate, Bone

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510(K) Number K230733
Device Name Plate, Bone
Applicant Stryker Leibinger GmbH & Co. KG
Boetzinger Strasse 41
Freiburg D-79111 DE
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Contact Gregory Gohl
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Regulation Number 872.4760

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Classification Product Code JEY
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Date Received 03/16/2023
Decision Date 08/05/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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