FDA 510(k) Application Details - K172794

Device Classification Name Laparoscope, General & Plastic Surgery

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510(K) Number K172794
Device Name Laparoscope, General & Plastic Surgery
Applicant WickiMed (Huizhou) Medical Equipment Manufacturing Co., Ltd.
Tang Jiao Xing Wang Street
LiLin Town, ZhongKai Hi-Tech Zone
Huizhou 516000 CN
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Contact Haobin Li
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Regulation Number 876.1500

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Classification Product Code GCJ
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Date Received 09/15/2017
Decision Date 11/29/2017
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



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