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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., NO. 58, SEC. 3
MINGCHAUN EAST ROAD
TAIPEI,  TW 104
Applicant Contact JEN KE-MIN
Correspondent
PROSBEN, INC.
11 F., NO. 58, SEC. 3
MINGCHAUN EAST ROAD
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
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