FDA 510(k) Application Details - K231725

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K231725
Device Name Laparoscope, General & Plastic Surgery
Applicant Hunan Endoso Life Technology Co., Ltd.
4th floor, Building 10, Innovation and Entrepreneurship
Center, 31 Dongfeng Road, Heping Street, Xiangtan Economic D
HuNan 411199 CN
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Contact Fu Wang
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 06/13/2023
Decision Date 10/16/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K231725


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