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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 K964696
Device Name SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
Applicant
SUNSOFT CORP.
6815 ACADEMY PKWY. WEST, N.E.
ALBUQUERQUE,  NM  87109
Applicant Contact JAMES B WILLIAMS
Correspondent
SUNSOFT CORP.
6815 ACADEMY PKWY. WEST, N.E.
ALBUQUERQUE,  NM  87109
Correspondent Contact JAMES B WILLIAMS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received11/22/1996
Decision Date 02/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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