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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 K884414
Device Name CLENSATRON AUTOMATIC CONTACT LENS CLEANER
Applicant
Questech Intl., Inc.
28 Marigold Ln.
Marlboro,  NJ  07746
Applicant Contact MARTIN S KNOPF
Correspondent
Questech Intl., Inc.
28 Marigold Ln.
Marlboro,  NJ  07746
Correspondent Contact MARTIN S KNOPF
Regulation Number886.5928
Classification Product Code
LYL  
Date Received10/20/1988
Decision Date 12/29/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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