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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.
 
DeviceRIGID GAS PERMEABLE CONTACT LENSES
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantThe Lifestyle Co., Inc.
712 Ginesi Dr.
Morganville, NJ 07751
PMA NumberP840055
Supplement NumberS022
Date Received04/11/1991
Decision Date05/06/1991
Product Code HQD 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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