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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Solution, Ultrasonic Cleaners For Lenses
510(k) Number K991965
Device Name PURILENS SYSTEM FOR CLEANING AND DISINFECTING CONTACT LENSES
Applicant
Purilens, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Applicant Contact RICHARD E LIPPMAN
Correspondent
Purilens, Inc.
12300 Twinbrook Pkwy., Suite 625
Rockville,  MD  20852
Correspondent Contact RICHARD E LIPPMAN
Regulation Number886.5928
Classification Product Code
LYL  
Subsequent Product Code
LPN  
Date Received06/10/1999
Decision Date 10/01/1999
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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