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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.
 
DeviceBOSTON(R) EQUALENS (R) SCLERAL CONTACT LENS DESIGN
Generic NameLens, contact (other material) - daily
Regulation Number886.5916
ApplicantBausch & Lomb
1400 N Goodman St.
Rochester, NY 14692
PMA NumberP860022
Supplement NumberS040
Date Received06/09/1992
Decision Date03/01/1994
Product Code HQD 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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