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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 K122700
Device Name PROSBEN CONTACT LENS CASES MODEL CA66-02, CA66-03WB, CA66-04T SERIES
Applicant
Prosben, Inc.
11 F., # 58, Sec. 3
Mingchaun E. Rd.
Taipei,  TW 104
Applicant Contact JEN KE-MIN
Correspondent
Prosben, Inc.
11 F., # 58, Sec. 3
Mingchaun E. Rd.
Taipei,  TW 104
Correspondent Contact JEN KE-MIN
Regulation Number886.5928
Classification Product Code
LRX  
Date Received09/04/2012
Decision Date 05/31/2013
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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