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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 K883854
Device Name DEXSOL
Applicant
Northern Scientific, Inc.
688 Main St.
Buffalo,  NY  14202
Applicant Contact CAROL HOUENSTEIN
Correspondent
Northern Scientific, Inc.
688 Main St.
Buffalo,  NY  14202
Correspondent Contact CAROL HOUENSTEIN
Classification Product Code
LYX  
Date Received09/13/1988
Decision Date 11/16/1988
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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