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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBOSTON EQUALENS/BOSTON EQUALENS II
Classification Namelens,contact(rigid gas permeable)-extended wear
Generic Namerigid gas permeable contact lens
Regulation Number886.5916
ApplicantBAUSCH & LOMB, INC.
PMA NumberP860022
Supplement NumberS053
Date Received09/25/2001
Decision Date11/21/2001
Product Code
MWL[ Registered Establishments with MWL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for wet shipping and up to 30 days storage in boston advance comfort formula conditioning solution.
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