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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 K970746
Device Name SEE3 (LOTRAFILCON A) SOFT CONTACT LENS
Applicant
Ciba Vision Corporation
11460 Johns Creek Pkwy.
Duluth,  GA  30097
Applicant Contact ALICIA M PLESNARSKI, RAC
Correspondent
Ciba Vision Corporation
11460 Johns Creek Pkwy.
Duluth,  GA  30097
Correspondent Contact ALICIA M PLESNARSKI, RAC
Regulation Number886.5925
Classification Product Code
LPL  
Date Received02/28/1997
Decision Date 05/09/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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