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FDA 510(k) Application Details - K180139
Device Classification Name
Wrap, Sterilization
More FDA Info for this Device
510(K) Number
K180139
Device Name
Wrap, Sterilization
Applicant
Safe Secure Packing Co., Ltd.
Yaoshan Industrial Park
Xiegang Town
Dongguan City 523601 CN
Other 510(k) Applications for this Company
Contact
Howard Jia
Other 510(k) Applications for this Contact
Regulation Number
880.6850
More FDA Info for this Regulation Number
Classification Product Code
FRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/18/2018
Decision Date
01/03/2019
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HO - General Hospital
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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