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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(ITAFLUOROFOCON A)/EQUALENS II(OPRIFOCON A)
Classification Namelens, contact (other material) - daily
Generic Nameextended wear contact lens
Regulation Number886.5916
ApplicantPOLYMER TECHNOLOGY CORP.
PMA NumberP860022
Supplement NumberS052
Date Received01/05/2000
Decision Date02/04/2000
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Type 30-Day Supplement
Supplement Reason location change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval under a 30-day notice for addition of one finishing laboratory, procornea nederland bv, kollergan9, nl-6961 lz eerbeek, the netherlands, to become an additional manufacturing and distributino site for the referenced devices.
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