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FDA 510(k) Application Details - K981103
Device Classification Name
Unit, Phacofragmentation
More FDA Info for this Device
510(K) Number
K981103
Device Name
Unit, Phacofragmentation
Applicant
ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH, TX 76134-2099 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
03/26/1998
Decision Date
06/23/1998
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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