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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 K980418
Device Name BENZ METHAFILCON A OPTICAL BLANK, BENZ METHAFILCON A SPHERICAL AND TORIC SOFT (HYDROPHILIC) CONTACT LENSES FOR DAILY WER
Applicant
Benz Research and Development Corp.
1070 Thornwood Ln.
Dacula,  GA  30019
Applicant Contact MICHAEL A CLARK
Correspondent
Benz Research and Development Corp.
1070 Thornwood Ln.
Dacula,  GA  30019
Correspondent Contact MICHAEL A CLARK
Regulation Number886.5925
Classification Product Code
LPL  
Date Received02/03/1998
Decision Date 02/27/1998
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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