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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Endoilluminator
510(k) Number K242184
Device Name Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256);
Applicant
Alcon Laboratories, Inc.
6201 S. Freeway
Fort Worth,,  TX  76134
Applicant Contact Ganesh Balachandar
Correspondent
Alcon Laboratories, Inc.
6201 S. Freeway
Fort Worth,,  TX  76134
Correspondent Contact Ganesh Balachandar
Regulation Number876.1500
Classification Product Code
MPA  
Date Received07/25/2024
Decision Date 12/04/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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