Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K142717
Device Classification Name
Case, Contact Lens
More FDA Info for this Device
510(K) Number
K142717
Device Name
Case, Contact Lens
Applicant
Ni Hau Industrial Co., Ltd.
No. 15, Alley 125, Lane 318, Section 2, An Ho Road
Tainan City 70967 TW
Other 510(k) Applications for this Company
Contact
Lyn Chiu
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
09/23/2014
Decision Date
05/07/2015
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
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact