Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K050336
Device Classification Name
Aberrometer, Ophthalmic
More FDA Info for this Device
510(K) Number
K050336
Device Name
Aberrometer, Ophthalmic
Applicant
NIDEK, INC.
21911 ERIE LN.
LAKE FOREST, CA 92630 US
Other 510(k) Applications for this Company
Contact
CAROL PATTERSON
Other 510(k) Applications for this Contact
Regulation Number
886.1760
More FDA Info for this Regulation Number
Classification Product Code
NCF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/10/2005
Decision Date
08/24/2005
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