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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 K960584
Device Name NOVANEW RECONDITIONING SYSTEM FOR PROF. USE IN-OFFICE USE ONLY
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 Received02/12/1996
Decision Date 08/15/1996
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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