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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Curette, Suction, Endometrial (And Accessories)
510(k) Number K240434
Device Name RELIEEV Suction Curette (Flexible 3.0/ Standard 3.6)
Applicant
Li Medical Corporation , Ltd.
2f., # 43, Zhongxing Rd.
New Taipei City,  TW 221012
Applicant Contact Jago Chen
Correspondent
Li Medical Corporation , Ltd.
2f., # 43, Zhongxing Rd.
New Taipei City,  TW 221012
Correspondent Contact Jago Chen
Regulation Number884.1175
Classification Product Code
HHK  
Date Received02/14/2024
Decision Date 09/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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