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FDA 510(k) Application Details - K983291
Device Classification Name
Products, Contact Lens Care, Rigid Gas Permeable
More FDA Info for this Device
510(K) Number
K983291
Device Name
Products, Contact Lens Care, Rigid Gas Permeable
Applicant
CIBA VISION CORPORATION
11460 JOHNS CREEK PKWY.
DULUTH, GA 30097 US
Other 510(k) Applications for this Company
Contact
STEVEN DOWDLEY
Other 510(k) Applications for this Contact
Regulation Number
886.5918
More FDA Info for this Regulation Number
Classification Product Code
MRC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/21/1998
Decision Date
11/25/1998
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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