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510(k) K220891

Kahook Dual Blade Glide (KDB Glide) by New World Medical, Inc. — Product Code QUQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2024
Date Received
March 28, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Knife, Intraocular Pressure Lowering
Device Class
Class II
Regulation Number
878.4400
Review Panel
OP
Submission Type

A knife intended for cutting of trabecular meshwork to reduce intraocular pressure in glaucoma

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