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FDA 510(k) Application Details - K162869
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K162869
Device Name
Case, Contact Lens
Applicant
Ningbo Yinzhou Zonghai Artware Co., Ltd.
Honglianchi, Guangsheng Village, Jishigang Town
Yinzhou District
Ningbo City 315172 CN
Other 510(k) Applications for this Company
Contact
Weng Changhai
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LRX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/13/2016
Decision Date
12/09/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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