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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 NameIPAFLUOROFOCON A AND B
Classification Namelens, contact (other material) - daily
Generic Nameextended wear contact lens
Regulation Number886.5916
ApplicantPOLYMER TECHNOLOGY CORP.
PMA NumberP860022
Supplement NumberS049
Date Received12/22/1997
Decision Date02/06/1998
Product Code
HQD[ Registered Establishments with HQD ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for one additional finishing laboratory to become an additional manufacturer and distributor of the contact lenses. The laboratory to be added is gelflex laboratories, 3 hutton street, osborne park, perth, wester australia 60017.
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