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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 K963001
Device Name LIFESTYLE 4-VUE (POLYMACON) HYDROPHILIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR
Applicant
Permeable Technologies, Inc.
6 Shadowbrook Dr.
Colts Neck,  NJ  07722
Applicant Contact MARTIN S KNOPF
Correspondent
Permeable Technologies, Inc.
6 Shadowbrook Dr.
Colts Neck,  NJ  07722
Correspondent Contact MARTIN S KNOPF
Regulation Number886.5925
Classification Product Code
LPL  
Date Received08/02/1996
Decision Date 03/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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