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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact, (Disposable)
510(k) Number K993252
Device Name METHAFILCON A SOFT HYDROPHILIC CONTACT LENSES, FREQUENCY 55, FREQUENCY 55 UV (TO BE MARKETED YR. 2000), FREQUENCY 55 ASP
Applicant
CooperVision, Inc.
711 N. Rd.
Scottsville,,  NY  14546
Applicant Contact BONNIE TSYMBAL
Correspondent
CooperVision, Inc.
711 N. Rd.
Scottsville,,  NY  14546
Correspondent Contact BONNIE TSYMBAL
Regulation Number886.5925
Classification Product Code
MVN  
Subsequent Product Code
LPL  
Date Received09/28/1999
Decision Date 11/24/1999
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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