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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K032309
Device Name NOVELENS CONTACT LENS CLEANING ENHANCEMENT AND STORAGE ACCESSORY
Applicant
Novelens, Inc.
15825 Shady Grove Rd.Suite 30
Rockville,  MD  20850
Applicant Contact RICHARD E LIPPMAN
Correspondent
Novelens, Inc.
15825 Shady Grove Rd.Suite 30
Rockville,  MD  20850
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.5928
Classification Product Code
LRX  
Date Received07/25/2003
Decision Date 12/04/2003
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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