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FDA 510(k) Application Details - K202709
Device Classification Name
Staple, Implantable
More FDA Info for this Device
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
Other 510(k) Applications for this Company
Contact
Hong Pengfei
Other 510(k) Applications for this Contact
Regulation Number
878.4750
More FDA Info for this Regulation Number
Classification Product Code
GDW
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More FDA Info for this Product Code
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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