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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 K974724
Device Name SOFTMATE AUTOMATIC LENS CLEANING UNIT, CLENSATRON 700 CL AUTOMATIC CONTACT LENS CLEANER, VISONIC DOME, LENSONIC CONTACT
Applicant
LENS COMFORT, INC.
912 BROAD ST.
ELIZABETH,  NJ  07208
Applicant Contact JAMES C DEMESTICHAS
Correspondent
LENS COMFORT, INC.
912 BROAD ST.
ELIZABETH,  NJ  07208
Correspondent Contact JAMES C DEMESTICHAS
Regulation Number886.5928
Classification Product Code
LYL  
Date Received12/18/1997
Decision Date 03/02/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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