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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lens, Contact (Other Material) - Daily
510(k) Number K955900
Device Name NOVALENS/NOVAWET SPHJERICAL & PERCEPTION & VANGUARD MULTIFOCAL &/OR BIFOCAL (ROSIFOCON A) RIGID GAS PERMEABLE CONTACT LR
Applicant
Novavision, Inc.
2700-200 Gateway Centre Blvd.
Morrisville,  NC  27560
Applicant Contact ALAN J TOUCH
Correspondent
Novavision, Inc.
2700-200 Gateway Centre Blvd.
Morrisville,  NC  27560
Correspondent Contact ALAN J TOUCH
Regulation Number886.5916
Classification Product Code
HQD  
Date Received12/29/1995
Decision Date 03/25/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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