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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lenses, soft contact, daily wear
510(k) Number K954139
Device Name AQUASOFT (TETRAFILCON A) DAILY WEAR SOFT (HYDROPHILIC) CONTACT LENS
Applicant
COOPERVISION, INC.
10 FARADAY
IRVINE,  CA  92618
Applicant Contact AMY BLAZAK
Correspondent
COOPERVISION, INC.
10 FARADAY
IRVINE,  CA  92618
Correspondent Contact AMY BLAZAK
Regulation Number886.5925
Classification Product Code
LPL  
Date Received09/01/1995
Decision Date 11/24/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
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