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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 K982115
Device Name LENSERVER AUTOMATIC CONTACT LENS CLEANING ACCESSORY
Applicant
Rim-Wide Companies, Inc.
P O Box 910184
San Diego,  CA  92191
Applicant Contact DANIEL HSU
Correspondent
Rim-Wide Companies, Inc.
P O Box 910184
San Diego,  CA  92191
Correspondent Contact DANIEL HSU
Regulation Number886.5928
Classification Product Code
LYL  
Date Received06/16/1998
Decision Date 01/13/1999
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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