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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 K965012
Device Name LIFESTYLE BREAK THRU (POLYMACON)
Applicant
The Lifestyle Co., Inc.
712 Ginesi Dr.
Morganville,  NJ  07751
Applicant Contact LEONARD SEIDNER, OD
Correspondent
The Lifestyle Co., Inc.
712 Ginesi Dr.
Morganville,  NJ  07751
Correspondent Contact LEONARD SEIDNER, OD
Regulation Number886.5925
Classification Product Code
LPL  
Date Received12/16/1996
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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