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FDA 510(k) Application Details - K173847
Device Classification Name
Gown, Surgical
More FDA Info for this Device
510(K) Number
K173847
Device Name
Gown, Surgical
Applicant
Xiantao Rayxin Medical Products Co., ltd.
No. 258 Pengchang Road, Middle Street
Xiantao 433018 CN
Other 510(k) Applications for this Company
Contact
Liang Zhang
Other 510(k) Applications for this Contact
Regulation Number
878.4040
More FDA Info for this Regulation Number
Classification Product Code
FYA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/19/2017
Decision Date
01/16/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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