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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Packed Cartridge
510(k) Number K232784
Device Name RELiZORB®
Applicant
Alcresta Therapeutics, Inc.
130 Turner St.
Bldg. 3, Suite 200
Waltham,  MA  02453
Applicant Contact Matthew King
Correspondent
Alcresta Therapeutics, Inc.
130 Turner St.
Bldg. 3, Suite 200
Waltham,  MA  02453
Correspondent Contact Matthew King
Regulation Number876.5985
Classification Product Code
PLQ  
Date Received09/11/2023
Decision Date 12/21/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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