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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Trade NameAOSEPT (R) LENS CUP & AODISC NEUTRALIZER
Classification Nameaccessories, soft lens products
Regulation Number886.5928
ApplicantCIBA VISION CARE
PMA NumberP820040
Supplement NumberS032
Date Received09/08/1994
Decision Date10/23/1995
Product Code
LPN[ Registered Establishments with LPN ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the currently approved aosept lens cup and aodisc neutralizer to inlcude a cup manufacturing site change, cup material change, cup and disc design change, and corresponding labeling changes. The new primary manufacturing site is tenax corporation, 124 franklin park avenue, youngsville, nc 27596. Secondary manufacturing site is tenax corp, 2450 laura duncan road, apex, nc 27502.
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