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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Perimeter, Automatic, Ac-Powered
510(k) Number K023623
Device Name NOVAVISION, MODEL 2.0
Applicant
NOVAVISION, INC.
1111 PENNSYLVANIA AVE N.W.
WASHINGTON,  DC  20004
Applicant Contact SANDRA J.P. DENNIS
Correspondent
NOVAVISION, INC.
1111 PENNSYLVANIA AVE N.W.
WASHINGTON,  DC  20004
Correspondent Contact SANDRA J.P. DENNIS
Regulation Number886.1605
Classification Product Code
HPT  
Date Received10/29/2002
Decision Date 04/22/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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