FDA 510(k) Application Details - K232633

Device Classification Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

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510(K) Number K232633
Device Name Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant Boston Scientific
100 Boston Scientific Way
Marborough, MA 01752 US
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Contact Lingling Guo
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Regulation Number 876.4300

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Classification Product Code KNS
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Date Received 08/30/2023
Decision Date 11/28/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K232633


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