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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.
 
DeviceTHE BOSTON EQUALENS (FLUROFOCON A) CONTACT LENS
Classification Namelens, contact (other material) - daily
Generic Namelens, contact (other material) - daily
Regulation Number886.5916
Applicant
POLYMER TECHNOLOGY CORP.
1400 n. goodman st.
rochester, NY 14692
PMA NumberP860022
Supplement NumberS001
Date Received01/15/1988
Decision Date08/22/1988
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
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