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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(R) AND BOSTON RXD(R)
Classification Namelens, contact (other material) - daily
Regulation Number886.5916
ApplicantPOLYMER TECHNOLOGY CORP.
PMA NumberP860022
Supplement NumberS046
Date Received04/27/1995
Decision Date06/05/1995
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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