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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 K964222
Device Name ACU-CLENS CLEANING SYSTEM FOR CONTACT LENS CLEANING
Applicant
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Applicant Contact ELAINE DUNCAN
Correspondent
Paladin Medical, Inc.
P.O. Box 560
Stillwater,  MN  55082
Correspondent Contact ELAINE DUNCAN
Regulation Number886.5928
Classification Product Code
LYL  
Date Received10/22/1996
Decision Date 12/20/1996
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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