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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Knife, Intraocular Pressure Lowering
510(k) Number K220891
Device Name Kahook Dual Blade Glide (KDB Glide)
Applicant
New World Medical, Inc.
10763 Edison Ct.
Rancho Cucamonga,  CA  91730
Applicant Contact Victor Arellano
Correspondent
New World Medical, Inc.
10763 Edison Ct.
Rancho Cucamonga,  CA  91730
Correspondent Contact Victor Arellano
Regulation Number878.4400
Classification Product Code
QUQ  
Date Received03/28/2022
Decision Date 05/17/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
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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