FDA 510(k) Application Details - K202709

Device Classification Name Staple, Implantable

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510(K) Number K202709
Device Name Staple, Implantable
Applicant Ningbo Verykind Medical Device Co., Ltd.
#100 Jinghua Road, Hi-tech industrial development zone
Ningbo 315040 CN
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Contact Hong Pengfei
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Regulation Number 878.4750

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Classification Product Code GDW
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Date Received 09/16/2020
Decision Date 05/18/2021
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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