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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSEPTICON(TM) DISINFECTION REGIMEN FOR USE WITH
Generic NameAccessories, soft lens products
Regulation Number886.5928
ApplicantCiba Vision Care
11460 Johns Creek Pkwy.
Duluth, GA 30136
PMA NumberP820040
Supplement NumberS019
Date Received01/27/1988
Decision Date05/06/1988
Product Code LPN 
Advisory Committee Ophthalmic
Supplement TypeSpecial (Immediate Track)
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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