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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Case, Contact Lens
510(k) Number K093377
Device Name POLARIS CONTACT LENS CASE
Applicant
Reliance Design & Manufacturing Corp.
3f, # 25 Yi-6th Rd.
Keelung,  TW 20148
Applicant Contact TRAVIS HSU
Correspondent
Underwriters Laboratories, Inc.
2600 NW Lake Rd.
Camas,  WA  98607
Regulation Number886.5928
Classification Product Code
LRX  
Date Received10/29/2009
Decision Date 04/27/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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