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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
510(k) Number K241750
Device Name Medifun Safety Lancet ( MSL1 series)
Applicant
Medifun Corporation
4F-1, 4F-9, 4F-10, No.99, Jingke S. Rd., Nantun Dist.,
Taichung City,  TW 408
Applicant Contact Aaron Chen
Correspondent
Voler Biotech Consulting CO., Ltd
6F.-17, No. 14, Ln. 609, Sec. 5, Chongxin Rd., Sanchong Dist
New Taipei City,  TW 241407
Correspondent Contact Mandy Lin
Regulation Number878.4850
Classification Product Code
FMK  
Date Received06/18/2024
Decision Date 08/15/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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