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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laparoscope, General & Plastic Surgery
510(k) Number K160801
Device Name Well Lead Extraction Bag
Applicant
WELL LEAD MEDICAL CO., LTD.
C-4 # JINHU INDUSTRIAL ESTATE, HUALONG, PANYU
GUANGZHOU,  CN 511434
Applicant Contact HAN GUANG YUAN
Correspondent
WELL LEAD MEDICAL CO., LTD.
C-4 # JINHU INDUSTRIAL ESTATE, HUALONG, PANYU
GUANGZHOU,  CN 511434
Correspondent Contact HAN GUANG YUAN
Regulation Number876.1500
Classification Product Code
GCJ  
Date Received03/23/2016
Decision Date 11/29/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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