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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 K032422
Device Name EUSOL-C
Applicant
Al.Chi.Mi.A
377 Rte. 17s
Hasbrouck Heights,  NJ  07604
Applicant Contact GEORGE MYERS
Correspondent
Al.Chi.Mi.A
377 Rte. 17s
Hasbrouck Heights,  NJ  07604
Correspondent Contact GEORGE MYERS
Classification Product Code
LYX  
Date Received08/05/2003
Decision Date 12/15/2003
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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