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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 K000529
Device Name LIFESTYLE MV2 (TM) TORIC (POLYMACON) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR (CLEAR OR TINTED)
Applicant
The Lifestyle Co., Inc.
712 Ginesi Dr.
Morganville,  NJ  07751
Applicant Contact MARTIN RIEHM
Correspondent
The Lifestyle Co., Inc.
712 Ginesi Dr.
Morganville,  NJ  07751
Correspondent Contact MARTIN RIEHM
Regulation Number886.5925
Classification Product Code
LPL  
Date Received02/17/2000
Decision Date 03/21/2000
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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