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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 K854052
Device Name CSM MEDIUM
Applicant
Northern Scientific, Inc.
688 Main St.
Buffalo,  NY  14202
Applicant Contact ROBERT W CASE
Correspondent
Northern Scientific, Inc.
688 Main St.
Buffalo,  NY  14202
Correspondent Contact ROBERT W CASE
Classification Product Code
LYX  
Date Received10/03/1985
Decision Date 12/31/1985
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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