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FDA 510(k) Application Details - K031788
Device Classification Name
Device,Analysis,Anterior Segment
More FDA Info for this Device
510(K) Number
K031788
Device Name
Device,Analysis,Anterior Segment
Applicant
MASSIE RESEARCH LABORATORIES, INC.
5775 W. LOS POSITAS
SUITE 200
PLEASANTON, CA 94588-4084 US
Other 510(k) Applications for this Company
Contact
N.A. (BERT) MASSIE
Other 510(k) Applications for this Contact
Regulation Number
886.1850
More FDA Info for this Regulation Number
Classification Product Code
MXK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/10/2003
Decision Date
09/02/2004
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
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