Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K191929
Device Classification Name
Lenses, Soft Contact, Daily Wear
More FDA Info for this Device
510(K) Number
K191929
Device Name
Lenses, Soft Contact, Daily Wear
Applicant
UNICON Optical CO., LTD
No 16, Gongye E. 9th Rd.
Hsinchu Science Park, Baoshan Township
Hsinchu County 30075 TW
Other 510(k) Applications for this Company
Contact
Hsiao-Wei Shen
Other 510(k) Applications for this Contact
Regulation Number
886.5925
More FDA Info for this Regulation Number
Classification Product Code
LPL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/19/2019
Decision Date
09/17/2019
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