FDA 510(k) Application Details - K232042

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K232042
Device Name Laparoscope, General & Plastic Surgery
Applicant MediConcepts Technology (Shenzhen) Company Limited
Building No. 37, Tongfu Industrial Estate, Dapeng New
District Shenzhen City, Guangdong Province, China
Shenzhen 518120 CN
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Contact Nick Xu
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 07/10/2023
Decision Date 10/20/2023
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 K232042


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