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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 NameTHE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS
Classification Namelens, contact (other material) - daily
Generic Nameflurofocon a rigid gas
Regulation Number886.5916
ApplicantPOLYMER TECHNOLOGY CORP.
PMA NumberP860022
Supplement NumberS016
Date Received05/05/1989
Decision Date12/27/1989
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
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