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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., No. 43, Zhongxing Rd.
New Taipei City,  TW 221012
Applicant Contact Jago Chen
Correspondent
Li Medical Corporation Ltd.
2F., No. 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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