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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Antistick
510(k) Number K252098
Device Name PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED / SD-23ED)
Applicant
Methyl Co., Ltd.
7f.-2, # 1, Guangfu S. Rd.
Taipei,  TW 105
Applicant Contact Stephanie Hsieh
Correspondent
Methyl Co., Ltd.
7f.-2, # 1, Guangfu S. Rd.
Taipei,  TW 105
Correspondent Contact Stephanie Hsieh
Regulation Number880.5860
Classification Product Code
MEG  
Subsequent Product Code
FMI  
Date Received07/03/2025
Decision Date 02/18/2026
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
Predetermined Change
Control Plan Authorized		 No
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