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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
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