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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lubricant, patient
510(k) Number K112110
Device Name STERILE LUBRICATING JELLY
Applicant
JIANERKANG MEDICAL DRESSING COMPANY
ZHIXI TOWN
JINTAN CITY, JIANGSU,  CN 213251
Applicant Contact JORDON CHU
Correspondent
JIANERKANG MEDICAL DRESSING COMPANY
ZHIXI TOWN
JINTAN CITY, JIANGSU,  CN 213251
Correspondent Contact JORDON CHU
Regulation Number880.6375
Classification Product Code
KMJ  
Date Received07/22/2011
Decision Date 04/10/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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