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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 K980634
Device Name FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
Applicant
Aspect Vision Care, Ltd.
90 W. Main St.
Freehold,  NJ  07728
Applicant Contact MARTIN S KNOPF
Correspondent
Aspect Vision Care, Ltd.
90 W. Main St.
Freehold,  NJ  07728
Correspondent Contact MARTIN S KNOPF
Regulation Number886.5925
Classification Product Code
LPL  
Date Received02/19/1998
Decision Date 04/22/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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