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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 K250499
Device Name RELiZORB (100300/100301)
Applicant
Alcresta Therapeutics, Inc.
130 Turner St.
Bldg. 3, Suite 200
Waltham,  MA  02453
Applicant Contact Daniel Orlando
Correspondent
Alcresta Therapeutics, Inc.
130 Turner St.
Bldg. 3, Suite 200
Waltham,  MA  02453
Correspondent Contact Rookmin Persaud
Regulation Number876.5985
Classification Product Code
PLQ  
Date Received02/20/2025
Decision Date 04/17/2025
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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