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FDA 510(k) Application Details - K093210
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K093210
Device Name
Unit, Phacofragmentation
Applicant
ALCON MANUFACTURING, LTD.
15800 ALTON PKWY.
IRVINE, CA 92618-3818 US
Other 510(k) Applications for this Company
Contact
MARTIN A KAUFMAN
Other 510(k) Applications for this Contact
Regulation Number
886.4670
More FDA Info for this Regulation Number
Classification Product Code
HQC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/13/2009
Decision Date
03/04/2010
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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