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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 K080794
Device Name POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
Applicant
Polyvue Distribution, Inc.
7077 Mcadams Ln.
Felton,  CA  95018
Applicant Contact GAROLD L EDWARDS
Correspondent
Polyvue Distribution, Inc.
7077 Mcadams Ln.
Felton,  CA  95018
Correspondent Contact GAROLD L EDWARDS
Regulation Number886.5925
Classification Product Code
LPL  
Date Received03/20/2008
Decision Date 12/17/2008
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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