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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 K921728
Device Name DEXSOL CORNEAL STORAGE MEDIA CONTAINER, MODIFIED
Applicant
Chiron Intraoptics
9342 Jeronimo Rd.
Irvine,  CA  92718
Applicant Contact CAROL L PATTERSON
Correspondent
Chiron Intraoptics
9342 Jeronimo Rd.
Irvine,  CA  92718
Correspondent Contact CAROL L PATTERSON
Classification Product Code
LYX  
Date Received03/25/1992
Decision Date 06/09/1992
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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