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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 K182965
Device Name BL-Cart IOL Delivery Cartridge
Applicant
AST Products, Inc.
9 Linnell Circle
Billerica,  MA  01821
Applicant Contact William Lee
Correspondent
Regulatory Doctor
9 Linnell Circle
Billerica,  MA  01821
Correspondent Contact William Lee
Regulation Number886.4300
Classification Product Code
MSS  
Date Received10/25/2018
Decision Date 03/29/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
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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