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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 K191379
Device Name RELiZORB
Applicant
Alcresta Therapeutics, Inc.
One Newton Executive Park
Suite 100
Newton,  MA  02462
Applicant Contact Eric First
Correspondent
Alcresta Therapeutics, Inc.
One Newton Executive Park
Suite 100
Newton,  MA  02462
Correspondent Contact Nandini Murthy
Regulation Number876.5985
Classification Product Code
PLQ  
Date Received05/23/2019
Decision Date 12/04/2019
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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