Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K961523
Device Classification Name
Sunglasses (Non-Prescription Including Photosensitive)
More FDA Info for this Device
510(K) Number
K961523
Device Name
Sunglasses (Non-Prescription Including Photosensitive)
Applicant
DORDA TOYS
2546 CORPORATE PLACE
SUITE B103
MONTEREY PARK, CA 91754 US
Other 510(k) Applications for this Company
Contact
MAY WONG
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
04/22/1996
Decision Date
05/13/1996
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