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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 K942374
Device Name ALLURE (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
Applicant
Sunsoft Corp.
6815 Academy Pkwy. W., N.E
Albuquerque,  NM  87109
Applicant Contact JAMES B WILLIAMS
Correspondent
Sunsoft Corp.
6815 Academy Pkwy. W., N.E
Albuquerque,  NM  87109
Correspondent Contact JAMES B WILLIAMS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received05/18/1994
Decision Date 04/13/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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