Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K964943
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
More FDA Info for this Device
510(K) Number
K964943
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
MICRON EYEWEAR MANUFACTORY CO., LTD.
UNIT 20, 5/F, WELL FUNG IND.
CTR., 68 TA CHUEN PING ST.,
KWAI CHUNG, N.T. HK
Other 510(k) Applications for this Company
Contact
CHRIS WONG SIU HING
Other 510(k) Applications for this Contact
Regulation Number
886.5850
More FDA Info for this Regulation Number
Classification Product Code
HQY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/1996
Decision Date
02/25/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OP - Ophthalmic
Review Advisory Committee
OP - Ophthalmic
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact