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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 K200057
Device Name bioli lOL Delivery System
Applicant
AST Products, Inc.
9 Linnell Circle
Billerica,  MA  01821
Applicant Contact William Lee
Correspondent
AST Products, Inc.
9 Linnell Circle
Billerica,  MA  01821
Correspondent Contact William Lee
Regulation Number886.4300
Classification Product Code
MSS  
Date Received01/13/2020
Decision Date 06/04/2020
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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