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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.
 
DeviceITAFLUOROFOCON A AND B
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantBausch & Lomb
1400 N Goodman St.
Rochester, NY 14692
PMA NumberP860022
Supplement NumberS051
Date Received03/12/1998
Decision Date03/31/1998
Product Code HQD 
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for an additional finishing laboratory to become an additional manufacturer and distributor for the device:Diversified Ophthalmics, 1308 West 500 North, Salt Lake City, UT 84116.
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