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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Corneal Storage
510(k) Number K954548
Device Name THE CHEN MEDIUM
Applicant
Chen Ophthalmic Laboratories
13704 Killarney Court
Phoenix,  MD  21131
Applicant Contact CHUNG-HO CHEN
Correspondent
Chen Ophthalmic Laboratories
13704 Killarney Court
Phoenix,  MD  21131
Correspondent Contact CHUNG-HO CHEN
Classification Product Code
LYX  
Date Received10/02/1995
Decision Date 05/20/1996
Decision Substantially Equivalent (SESE)
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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