FDA 510(k) Application Details - K223596

Device Classification Name Rongeur, Manual

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510(K) Number K223596
Device Name Rongeur, Manual
Applicant Aesculap Inc.
3773 Corporate Parkway
Center Valley, PA 18034 US
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Contact Benjamin Oswald
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Regulation Number 882.4840

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Classification Product Code HAE
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Date Received 12/02/2022
Decision Date 06/29/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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