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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 K992692
Device Name EXTREME H20 (HIOXIFILICON A) SOFT CONTACT LENS
Applicant
Benz Research and Development Corp.
P.O. Box 1839
Sarasota,  FL  34230 -1839
Applicant Contact JOSE A ORS
Correspondent
Benz Research and Development Corp.
P.O. Box 1839
Sarasota,  FL  34230 -1839
Correspondent Contact JOSE A ORS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received08/11/1999
Decision Date 10/18/1999
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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