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FDA 510(k) Application Details - K983973
Device Classification Name
Accessories, Soft Lens Products
More FDA Info for this Device
510(K) Number
K983973
Device Name
Accessories, Soft Lens Products
Applicant
ALCON LABORATORIES
6201 SOUTH FREEWAY
R7-14
FORT WORTH, TX 76134-2099 US
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Contact
MICHAEL PFLEGER
Other 510(k) Applications for this Contact
Regulation Number
886.5928
More FDA Info for this Regulation Number
Classification Product Code
LPN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/09/1998
Decision Date
12/18/1998
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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