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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name clip, implantable
510(k) Number K202994
Device Name InnoClip Disposable Clip Applier, InnoClip Clip Applier
Applicant
Taiwan Surgical Corporation
3F., No.12, Sec.2, ShengYi Rd.
Zhubei City,  TW 30261
Applicant Contact Ken Chen
Correspondent
Taiwan Surgical Corporation
3F., No.12, Sec.2, ShengYi Rd.
Zhubei City,  TW 30261
Correspondent Contact Ken Chen
Regulation Number878.4300
Classification Product Code
FZP  
Subsequent Product Code
GDO  
Date Received10/01/2020
Decision Date 01/04/2022
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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