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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 K211786
Device Name Independent Corneal Viewing Chamber (IVC-21)
Applicant
Bausch + Lomb, Incorporated
3365 Tree Court Industrial Blvd.
St. Louis,  MO  63122
Applicant Contact Heather Christie
Correspondent
Bausch + Lomb, Incorporated
3365 Tree Court Industrial Blvd.
St. Louis,  MO  63122
Correspondent Contact Heather Christie
Classification Product Code
LYX  
Date Received06/09/2021
Decision Date 12/03/2021
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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