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FDA 510(k) Application Details - K984443
Device Classification Name
Device,Analysis,Anterior Segment
More FDA Info for this Device
510(K) Number
K984443
Device Name
Device,Analysis,Anterior Segment
Applicant
TECHNOLAS PERFECT VISION GMBH
PO BOX 17190
ANAHEIM, CA 92817-7190 US
Other 510(k) Applications for this Company
Contact
BETSY M JOHNSON
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
12/14/1998
Decision Date
03/05/1999
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
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