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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enteral Specific Transition Connectors
510(k) Number K233190
Device Name ENFit Adaptor
Applicant
Jiangsu Caina Medical Co.,Ltd
# 23, Huanxi Rd. Zhutang Town
Jiangyin,  CN 214415
Applicant Contact Camel Zhou
Correspondent
Jiangsu Caina Medical Co.,Ltd
# 23, Huanxi Rd. Zhutang Town
Jiangyin,  CN 214415
Correspondent Contact Camel Zhou
Regulation Number876.5980
Classification Product Code
PIO  
Date Received09/28/2023
Decision Date 01/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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