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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 NameITAFLUOROFOCON A AND B
Classification Namelens, contact (other material) - daily
Generic Nameextended wear contact lens
Regulation Number886.5916
ApplicantBAUSCH AND LOMB INTERNATIONAL HOLDINGS CORP.
PMA NumberP860022
Supplement NumberS051
Date Received03/12/1998
Decision Date03/31/1998
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 for an additional finishing laboratory to become an additional manufacturer and distributor for the device:diversified ophthalmics, 1308 west 500 north, salt lake city, ut 84116.
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