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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 K063304
Device Name LIFE4C
Applicant
Numedis, Inc.
188 Bumstead Rd.
Monson,  MA  01057
Applicant Contact MARY E FREDDO
Correspondent
Numedis, Inc.
188 Bumstead Rd.
Monson,  MA  01057
Correspondent Contact MARY E FREDDO
Classification Product Code
LYX  
Date Received11/01/2006
Decision Date 12/21/2007
Decision Substantially Equivalent (SESE)
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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