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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 K863129
Device Name 3M CORNEAL SYSTEM (CORNEAL PRESERVATION MEDIUM)
Applicant
3M Company
Bldg.s 251-3 And 270
St. Paul,  MN  55144 -1000
Applicant Contact JULIA WANNAMAKER
Correspondent
3M Company
Bldg.s 251-3 And 270
St. Paul,  MN  55144 -1000
Correspondent Contact JULIA WANNAMAKER
Classification Product Code
LYX  
Date Received08/15/1986
Decision Date 09/17/1986
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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