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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name folders and injectors, intraocular lens (iol)
510(k) Number K212039
Device Name CLAREON MONARCH IV IOL Delivery System
Applicant
ALCON LABORATORIES, INC.
6201 South Freeway
Fort Worth,  TX  76134
Applicant Contact Jwalitha Shankardas
Correspondent
ALCON LABORATORIES,INC
6201 South Freeway
Fort Worth,  TX  76134
Correspondent Contact Jwalitha Shankardas
Regulation Number886.4300
Classification Product Code
MSS  
Date Received06/30/2021
Decision Date 08/23/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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