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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 K973192
Device Name FLEXLENS, FLEXLENS TORIC
Applicant
Specialty Ultravision, Inc.
84 W. Main St.
Freehold,  NJ  07728
Applicant Contact MARTIN S KNOPF
Correspondent
Specialty Ultravision, Inc.
84 W. Main St.
Freehold,  NJ  07728
Correspondent Contact MARTIN S KNOPF
Regulation Number886.5925
Classification Product Code
LPL  
Date Received08/25/1997
Decision Date 11/20/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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